Pregabalin
Capsule · Oral
Uses
Pregabalin is indicated for:
• Management of neuropathic pain associated with diabetic peripheral neuropathy
• Management of postherpetic neuralgia
• Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
• Management of fibromyalgia
• Management of neuropathic pain associated with spinal cord injury Pregabalin is indicated for:
• Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 )
• Postherpetic neuralgia (PHN) ( 1 )
• Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1 )
• Fibromyalgia ( 1 )
• Neuropathic pain associated with spinal cord injury ( 1 )
Dosage and administration
• For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4 . ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 )
• Dosing recommendations: INDICATION Dosing Regimen Maximum Dose DPN Pain ( 2.2 ) 3 divided doses per day 300 mg/day within 1 week. PHN ( 2.3 ) 2 or 3 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More ( 2.4 ) 2 or 3 divided doses per day Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg ( 2.4 ) 1 month to less than 4 years: 3 divided doses per day 4 years and older: 2 or 3 divided doses per day 14 mg/kg/day. Fibromyalgia ( 2.5 ) 2 divided doses per day 300 mg/day within 1 week. Maximum dose of 450 mg/day. Neuropathic Pain Associated with Spinal Cord Injury ( 2.6 ) 2 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day.
• Dose should be adjusted in adult patients with reduced renal function. ( 2.7 ) 2.1 Important Administration Instructions Pregabalin is given orally with or without food. When discontinuing pregabalin, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.4) ] . Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7) ] . 2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults The maximum recommended dose of pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1) ] . 2.3 Postherpetic Neuralgia in Adults The recommended dose of pregabalin is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1) ] . 2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly. Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older Age and Body Weight Recommended Initial Dosage Recommended Maximum Dosage Frequency of Administration Adults (17 years and older) 150 mg/day 600 mg/day 2 or 3 divided doses Pediatric patients weighing 30 kg or more 2.5 mg/kg/day 10 mg/kg/day (not to exceed 600 mg/day) 2 or 3 divided doses Pediatric patients weighing less than 30 kg 3.5 mg/kg/day 14 mg/kg/day 1 month to less than 4 years of age: 3 divided doses 4 years of age and older: 2 or 3 divided doses Both the efficacy and adverse event profiles of pregabalin have been shown to be dose-related. The effect of dose escalation rate on the tolerability of pregabalin has not been formally studied. The efficacy of adjunctive pregabalin in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin with gabapentin cannot be offered. 2.5 Management of Fibromyalgia in Adults The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1) ] . 2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults The recommended dose range of pregabalin for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate pregabalin may be treated with up to 300 mg two times a day [see Clinical Studies (14.5) ] .
Dosage forms and strengths
Oral Solution: 20 mg/mL [See Description (11) and How Supplied/Storage and Handling (16) .]
• Oral Solution: 20 mg/mL. ( 3 )
Contraindications
Pregabalin oral solution is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2) ] .
• Known hypersensitivity to pregabalin or any of its components. ( 4 )
Warnings and precautions
• Angioedema (e.g., swelling of the throat, head, and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in these cases. ( 5.1 )
• Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue pregabalin immediately in these patients. ( 5.2 )
• Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. ( 5.3 )
• Abrupt or rapid discontinuation may increase the risk for seizures. Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation. Taper pregabalin gradually over a minimum of 1 week. ( 5.4 )
• Respiratory depression: May occur with pregabalin, when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. ( 5.5 )
• Pregabalin may cause dizziness and somnolence and impair patients’ ability to drive or operate machinery. ( 5.6 )
• Pregabalin may cause peripheral edema. Exercise caution when co-administering pregabalin and thiazolidinedione antidiabetic agents. ( 5.7 ) 5.1 Angioedema There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with these symptoms. Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema. 5.2 Hypersensitivity There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue pregabalin immediately in patients with these symptoms. 5.3 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.4) ] . Monitor patients treated with any AED for any Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.4) ]. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs. Table 3. Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing pregabalin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Side effects
The following serious adverse reactions are described elsewhere in the labeling:
• Angioedema [see Warnings and Precautions (5.1) ]
• Hypersensitivity [see Warnings and Precautions (5.2) ]
• Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ]
• Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ]
• Respiratory Depression [see Warnings and Precautions (5.5) ]
• Dizziness and Somnolence [see Warnings and Precautions (5.6) ]
• Peripheral Edema [see Warnings and Precautions (5.7) ]
• Weight Gain [see Warnings and Precautions (5.8) ]
• Tumorigenic Potential [see Warnings and Precautions (5.9) ]
• Ophthalmological Effects [see Warnings and Precautions (5.10) ]
• Creatine Kinase Elevations [see Warnings and Precautions (5.11) ]
• Decreased Platelet Count [see Warnings and Precautions (5.12) ]
• PR Interval Prolongation [see Warnings and Precautions (5.13) ] Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). ( 6.1 ) Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years. Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies In premarketing controlled trials of all adult populations combined, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the pregabalin group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each). Most Common Adverse Reactions in All Controlled Clinical Studies in Adults In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo). Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy Adverse Reactions Leading to Discontinuation In clinical trials in adults with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients. Most Common Adverse Reactions Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”. Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy Body system Preferred term 75 mg/day [N=77] % 150 mg/day [N=212] % 300 mg/day [N=321] % 600 mg/day [N=369] % All PGB PGB: pregabalin [N=979] % Placebo [N=459] % Body as a whole Asthenia 4 2 4 7 5 2 Accidental injury 5 2 2 6 4 3 Back pain 0 2 1 2 2 0 Chest pain 4 1 1 2 2 1 Face edema 0 1 1 2 1 0 Digestive system Dry mouth 3 2 5 7 5 1 Constipation 0 2 4 6 4 2 Flatulence 3 0 2 3 2 1 Metabolic and nutritional disorders Peripheral edema 4 6 9 12 9 2 Weight gain 0 4 4 6 4 0 Edema 0 2 4 2 2 0 Hypoglycemia 1 3 2 1 2 1 Nervous system Dizziness 8 9 23 29 21 5 Somnolence 4 6 13 16 12 3 Neuropathy 9 2 2 5 4 3 Ataxia 6 1 2 4 3 1 Vertigo 1 2 2 4 3 1 Confusion 0 1 2 3 2 1 Euphoria 0 0 3 2 2 0 Incoordination 1 0 2 2 2 0 Thinking abnormal Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
Drug interactions
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs [see Clinical Pharmacology (12) ] . Pharmacodynamics Multiple oral doses of pregabalin were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when pregabalin was co-administered with these drugs. No clinically important effects on respiration were seen. Drug Interactions In Vitro Studies Pregabalin, at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 enzyme systems. In vitro drug interaction studies demonstrate that pregabalin does not induce CYP1A2 or CYP3A4 activity. Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g., theophylline, caffeine) or CYP3A4 substrates (e.g., midazolam, testosterone) is not anticipated. In Vivo Studies The drug interaction studies described in this section were conducted in healthy adults, and across various patient populations.
Use in specific populations
• Lactation: Breastfeeding is not recommended. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary Observational studies on the use of pregabalin during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data ) . Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin. Postmarketing data suggest that extended gabapentinoid use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone (see Clinical Considerations ) . There are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to pregabalin alone late in pregnancy may cause withdrawal signs and symptoms. In animal reproduction studies, increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including skeletal malformations, retarded ossification, and decreased fetal body weight were observed in the offspring of rats and rabbits given pregabalin orally during organogenesis, at doses that produced plasma pregabalin exposures (AUC) greater than or equal to 16 times human exposure at the maximum recommended dose (MRD) of 600 mg/day (see Data ) . In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation. The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentinoids in utero for an extended period of time when also exposed to opioids close to delivery. Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern, and tremor. Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements. Observe neonates exposed to pregabalin and opioids for signs and symptoms of neonatal withdrawal and manage accordingly. Data Human Data One database study, which included over 2,700 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 3,063,251 pregnancies unexposed to antiepileptics demonstrated prevalence ratios for major malformations overall of 1.14 (CI 95% 0.96-1.35) for pregabalin, 1.29 (CI 95% 1.01-1.65) for lamotrigine, 1.39 (CI 95% 1.07-1.82) for duloxetine, and 1.24 (CI 95% 1.00-1.54) for exposure to either lamotrigine or duloxetine. Important study limitations include uncertainty of whether women who filled a prescription took the medication and inability to adequately control for the underlying disease and other potential confounders. A published study included results from two separate databases. One database, which included 353 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 368,489 pregnancies unexposed to antiepileptics, showed no increase in risk of major birth defects; adjusted relative risk 0.87 (CI 95% 0.53-1.42). The second database, which included 118 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 380,347 pregnancies unexposed to antiepileptics, suggested a small increase in risk of major birth defects; adjusted relative risk 1.26 (CI 95% 0.64-2.49). The risk estimates crossed the null, and the study had limitations similar to the prior study. Other published epidemiologic studies reported inconsistent findings. No specific pattern of birth defects was identified across studies. All of the studies had limitations due to their retrospective design. Animal Data When pregnant rats were given pregabalin (500, 1250, or 2500 mg/kg) orally throughout the period of organogenesis, incidences of specific skull alterations attributed to abnormally advanced ossification (premature fusion of the jugal and nasal sutures) were increased at greater than or equal to 1250 mg/kg, and incidences of skeletal variations and retarded ossification were increased at all doses. Fetal body weights were decreased at the highest dose. The low dose in this study was associated with a plasma exposure (AUC) approximately 17 times human exposure at the MRD of 600 mg/day. A no-effect dose for rat embryo-fetal developmental toxicity was not established. When pregnant rabbits were given pregabalin (250, 500, or 1250 mg/kg) orally throughout the period of organogenesis, decreased fetal body weight and increased incidences of skeletal malformations, visceral variations, and retarded ossification were observed at the highest dose.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary Observational studies on the use of pregabalin during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data ) . Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin. Postmarketing data suggest that extended gabapentinoid use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone (see Clinical Considerations ) . There are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to pregabalin alone late in pregnancy may cause withdrawal signs and symptoms. In animal reproduction studies, increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including skeletal malformations, retarded ossification, and decreased fetal body weight were observed in the offspring of rats and rabbits given pregabalin orally during organogenesis, at doses that produced plasma pregabalin exposures (AUC) greater than or equal to 16 times human exposure at the maximum recommended dose (MRD) of 600 mg/day (see Data ) . In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation. The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentinoids in utero for an extended period of time when also exposed to opioids close to delivery. Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern, and tremor. Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements. Observe neonates exposed to pregabalin and opioids for signs and symptoms of neonatal withdrawal and manage accordingly. Data Human Data One database study, which included over 2,700 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 3,063,251 pregnancies unexposed to antiepileptics demonstrated prevalence ratios for major malformations overall of 1.14 (CI 95% 0.96-1.35) for pregabalin, 1.29 (CI 95% 1.01-1.65) for lamotrigine, 1.39 (CI 95% 1.07-1.82) for duloxetine, and 1.24 (CI 95% 1.00-1.54) for exposure to either lamotrigine or duloxetine. Important study limitations include uncertainty of whether women who filled a prescription took the medication and inability to adequately control for the underlying disease and other potential confounders. A published study included results from two separate databases. One database, which included 353 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 368,489 pregnancies unexposed to antiepileptics, showed no increase in risk of major birth defects; adjusted relative risk 0.87 (CI 95% 0.53-1.42). The second database, which included 118 pregnancies exposed to pregabalin (monotherapy) during the first trimester compared to 380,347 pregnancies unexposed to antiepileptics, suggested a small increase in risk of major birth defects; adjusted relative risk 1.26 (CI 95% 0.64-2.49). The risk estimates crossed the null, and the study had limitations similar to the prior study. Other published epidemiologic studies reported inconsistent findings. No specific pattern of birth defects was identified across studies. All of the studies had limitations due to their retrospective design. Animal Data When pregnant rats were given pregabalin (500, 1250, or 2500 mg/kg) orally throughout the period of organogenesis, incidences of specific skull alterations attributed to abnormally advanced ossification (premature fusion of the jugal and nasal sutures) were increased at greater than or equal to 1250 mg/kg, and incidences of skeletal variations and retarded ossification were increased at all doses. Fetal body weights were decreased at the highest dose. The low dose in this study was associated with a plasma exposure (AUC) approximately 17 times human exposure at the MRD of 600 mg/day. A no-effect dose for rat embryo-fetal developmental toxicity was not established. When pregnant rabbits were given pregabalin (250, 500, or 1250 mg/kg) orally throughout the period of organogenesis, decreased fetal body weight and increased incidences of skeletal malformations, visceral variations, and retarded ossification were observed at the highest dose.
Pediatric use
8.4 Pediatric Use Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury Safety and effectiveness in pediatric patients have not been established. Fibromyalgia Safety and effectiveness in pediatric patients have not been established. A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years, at pregabalin total daily doses of 75-450 mg per day. The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity (derived from an 11-point numeric rating scale) showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. Adjunctive Therapy for Partial-Onset Seizures Safety and effectiveness in pediatric patients below the age of 1 month have not been established. 4 to Less Than 17 Years of Age with Partial-Onset Seizures The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled study (n=295) [see Clinical Studies (14.3) ] . Patients treated with pregabalin 10 mg/kg/day had, on average, a 21.0% greater reduction in partial-onset seizures than patients treated with placebo (p=0.0185). Patients treated with pregabalin 2.5 mg/kg/day had, on average, a 10.5% greater reduction in partial-onset seizures than patients treated with placebo, but the difference was not statistically significant (p=0.2577). Responder rates (50% or greater reduction in partial-onset seizure frequency) were a key secondary efficacy parameter and showed numerical improvement with pregabalin compared with placebo: the responder rates were 40.6%, 29.1%, and 22.6%, for pregabalin 10 mg/kg/day, pregabalin 2.5 mg/kg/day, and placebo, respectively. The most common adverse reactions (≥ 5%) with pregabalin in this study were somnolence, weight increased, and increased appetite [see Adverse Reactions (6.1) ] . The use of pregabalin 2.5 mg/kg/day in pediatric patients is further supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures and pharmacokinetic data from adult and pediatric patients [see Clinical Pharmacology (12.3) ] . 1 Month to Less Than 4 Years of Age with Partial-Onset Seizures The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 1 month to less than 4 years of age have been established in a 14-day double-blind, placebo-controlled study (N=175) [see Clinical Studies (14.3) ] . The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses. Patients treated with pregabalin 14 mg/kg/day had, on average, 43.9% greater reduction in partial-onset seizures than patients treated with placebo (p=0.0223). In addition, pediatric patients treated with pregabalin 14 mg/kg/day showed numerical improvement in responder rates (≥ 50% reduction in partial-onset seizure frequency) compared with placebo (53.6% versus 41.5%). Patients treated with pregabalin 7 mg/kg/day did not show improvement relative to placebo for either endpoint. The most common dose-related adverse reactions (≥ 5%) with pregabalin in this study were somnolence, pneumonia, and viral infection [see Adverse Reactions (6.1) ] . Juvenile Animal Data In studies in which pregabalin (50 to 500 mg/kg) was orally administered to young rats from early in the postnatal period (Postnatal Day 7) through sexual maturity, neurobehavioral abnormalities (deficits in learning and memory, altered locomotor activity, decreased auditory startle responding and habituation) and reproductive impairment (delayed sexual maturation and decreased fertility in males and females) were observed at doses greater than or equal to 50 mg/kg. The neurobehavioral changes of acoustic startle persisted at greater than or equal to 250 mg/kg and locomotor activity and water maze performance at greater than or equal to 500 mg/kg in animals tested after cessation of dosing and, thus, were considered to represent long-term effects. The low effect dose for developmental neurotoxicity and reproductive impairment in juvenile rats (50 mg/kg) was associated with a plasma pregabalin exposure (AUC) approximately equal to human exposure at the maximum recommended dose of 600 mg/day. A no-effect dose was not established.
Geriatric use
8.5 Geriatric Use In controlled clinical studies of pregabalin in neuropathic pain associated with diabetic peripheral neuropathy, 246 patients were 65 to 74 years of age, and 73 patients were 75 years of age or older. In controlled clinical studies of pregabalin in neuropathic pain associated with postherpetic neuralgia, 282 patients were 65 to 74 years of age, and 379 patients were 75 years of age or older. In controlled clinical studies of pregabalin in epilepsy, there were only 10 patients 65 to 74 years of age, and 2 patients who were 75 years of age or older. No overall differences in safety and efficacy were observed between these patients and younger patients. In controlled clinical studies of pregabalin in fibromyalgia, 106 patients were 65 years of age or older. Although the adverse reaction profile was similar between the two age groups, the following neurological adverse reactions were more frequent in patients 65 years of age or older: dizziness, vision blurred, balance disorder, tremor, confusional state, coordination abnormal, and lethargy. Pregabalin is known to be substantially excreted by the kidney, and the risk of toxic reactions to pregabalin may be greater in patients with impaired renal function. Because pregabalin is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment [see Dosage and Administration (2.7) ] .
Overdosage
Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans In the postmarketing experience, the most commonly reported adverse events observed with pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state, agitation, and restlessness. Seizures and heart block have also been reported. Deaths have been reported in the setting of lone pregabalin overdose and in combination with other CNS depressants. Treatment or Management of Overdose There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with pregabalin. Pregabalin can be removed by hemodialysis. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
Description
Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients. Pregabalin Structural Formula
Mechanism of action
12.1 Mechanism of Action Pregabalin binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha 2 -delta subunit may be involved in pregabalin’s anti-nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium-dependent release of pro-nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha 2 -delta containing-calcium channel trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage and persistent pain suggest the anti-nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord. While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA A , GABA B , or benzodiazepine receptors, does not augment GABA A responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.
How supplied
20 mg/mL oral solution: 16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure: 16 fluid ounce bottle NDC 59762-1576-1 Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Angioedema Advise patients that pregabalin may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue pregabalin and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1) ] . Hypersensitivity Advise patients that pregabalin has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue pregabalin and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2) ] . Suicidal Thinking and Behavior Counsel patients, their caregivers, and families that AEDs, including pregabalin, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers. Also inform patients who plan to or have discontinued LYRICA that suicidal thoughts and behavior can appear even after the drug is stopped [see Warnings and Precautions (5.3) ] . Respiratory Depression Inform patients about the risk of respiratory depression. Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions (5.5) ] . Dizziness and Somnolence Counsel patients that pregabalin may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on pregabalin to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.6) ] . CNS Depressants Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as respiratory depression, somnolence, and dizziness [see Warnings and Precautions (5.5 , 5.6) and Drug Interactions (7) ] . Advise patients to avoid consuming alcohol while taking pregabalin, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol. Adverse Reactions with Abrupt or Rapid Discontinuation Advise patients to take pregabalin as prescribed. Abrupt or rapid discontinuation may result in increased seizure frequency in patients with seizure disorders, and insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea [see Warnings and Precautions (5.4) ] . Missed Dose Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time. Weight Gain and Edema Counsel patients that pregabalin may cause edema and weight gain. Advise patients that concomitant treatment with pregabalin and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure [see Warnings and Precautions (5.7 , 5.8) ] . Ophthalmological Effects Counsel patients that pregabalin may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.10) ] . Creatine Kinase Elevations Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever [see Warnings and Precautions (5.11) ] . Use in Pregnancy Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy [see Use in Specific Populations (8.1) and (8.2) ] . Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations (8.1) ] . Lactation Advise nursing mothers that breastfeeding is not recommended during treatment with pregabalin [see Use in Specific Populations (8.2) ] . Male Fertility Inform men being treated with pregabalin who plan to father a child of the potential risk of male-mediated teratogenicity. In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical significance of this finding is uncertain [see Nonclinical Toxicology (13.1) and Use in Specific Populations (8.3) ] . Dermatopathy Instruct diabetic patients to pay particular attention to skin integrity while being treated with pregabalin and to inform their healthcare provider about any sores or skin problems. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with pregabalin was observed in clinical trials [see Nonclinical Toxicology (13.2) ] . GREENSTONE ® BRAND Distributed by: Greenstone LLC Morgantown, WV 26505 U.S.A. © 2025 Viatris Inc. The brands listed are trademarks of their respective owners. GST:PREG:R2
Label text from the FDA structured product label by Mylan Pharmaceuticals Inc. (revised Apr 12, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Pregabalin in 510 products
Pregabalin NDC products (510)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6504 | Pregabalin 200 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CV |
| 50090-6793 | Pregabalin 75 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CV |
| 50090-7983 | Pregabalin 200 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CV |
| 50090-6503 | Pregabalin 100 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CV |
| 50090-5071 | Pregabalin 75 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CV |
| 50090-5038 | Pregabalin 75 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CV |
| 72888-050 | Pregabalin 165 mg/1 Tablet, Film Coated, Extended Release | Advagen Pharma Ltd. | ANDA · DEA CV |
| 72888-051 | Pregabalin 330 mg/1 Tablet, Film Coated, Extended Release | Advagen Pharma Ltd. | ANDA · DEA CV |
| 72888-049 | Pregabalin 82.5 mg/1 Tablet, Film Coated, Extended Release | Advagen Pharma Ltd. | ANDA · DEA CV |
| 80425-0026 | Pregabalin 50 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0399 | Pregabalin 225 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0397 | Pregabalin 150 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0030 | Pregabalin 75 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0029 | Pregabalin 75 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0028 | Pregabalin 75 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0027 | Pregabalin 50 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0025 | Pregabalin 50 mg/1 Capsule | Advanced Rx of Tennessee, LLC | ANDA · DEA CV |
| 80425-0421 | Pregabalin 50 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0178 | Pregabalin 150 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0185 | Pregabalin 150 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0277 | Pregabalin 100 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0308 | Pregabalin 200 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0327 | Pregabalin 50 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0177 | Pregabalin 300 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0170 | Pregabalin 100 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0417 | Pregabalin 75 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0433 | Pregabalin 25 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0160 | Pregabalin 300 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0152 | Pregabalin 50 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0147 | Pregabalin 75 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0129 | Pregabalin 300 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0124 | Pregabalin 150 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 80425-0123 | Pregabalin 100 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CV |
| 62332-125 | Pregabalin 225 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-124 | Pregabalin 200 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-123 | Pregabalin 150 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-122 | Pregabalin 100 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-121 | Pregabalin 75 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-120 | Pregabalin 50 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-126 | Pregabalin 300 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 62332-119 | Pregabalin 25 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CV |
| 46708-123 | Pregabalin 150 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-124 | Pregabalin 200 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-121 | Pregabalin 75 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-125 | Pregabalin 225 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-126 | Pregabalin 300 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-119 | Pregabalin 25 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-120 | Pregabalin 50 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 46708-122 | Pregabalin 100 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CV |
| 60687-484 | Pregabalin 50 mg/1 Capsule | American Health Packaging | ANDA · DEA CV |
| 60687-495 | Pregabalin 75 mg/1 Capsule | American Health Packaging | ANDA · DEA CV |
| 60687-473 | Pregabalin 25 mg/1 Capsule | American Health Packaging | ANDA · DEA CV |
| 60687-517 | Pregabalin 150 mg/1 Capsule | American Health Packaging | ANDA · DEA CV |
| 60687-506 | Pregabalin 100 mg/1 Capsule | American Health Packaging | ANDA · DEA CV |
| 69238-1317 | Pregabalin 300 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1310 | Pregabalin 25 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1311 | Pregabalin 50 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1310 | Pregabalin 25 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1312 | Pregabalin 75 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1311 | Pregabalin 50 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1312 | Pregabalin 75 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1316 | Pregabalin 225 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1315 | Pregabalin 200 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1314 | Pregabalin 150 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 69238-1313 | Pregabalin 100 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1313 | Pregabalin 100 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1314 | Pregabalin 150 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1315 | Pregabalin 200 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1316 | Pregabalin 225 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 60219-1317 | Pregabalin 300 mg/1 Capsule | Amneal Pharmaceuticals NY LLC | ANDA · DEA CV |
| 71610-758 | Pregabalin 75 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-998 | Pregabalin 150 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-759 | Pregabalin 200 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-760 | Pregabalin 225 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-765 | Pregabalin 75 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-808 | Pregabalin 100 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-800 | Pregabalin 300 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-799 | Pregabalin 75 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-792 | Pregabalin 25 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-931 | Pregabalin 25 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-997 | Pregabalin 200 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-996 | Pregabalin 300 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-995 | Pregabalin 225 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-994 | Pregabalin 100 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-993 | Pregabalin 25 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-948 | Pregabalin 200 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-947 | Pregabalin 225 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-946 | Pregabalin 225 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-936 | Pregabalin 100 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-820 | Pregabalin 50 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-930 | Pregabalin 50 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 53401-007 | Pregabalin 50 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-926 | Pregabalin 200 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-925 | Pregabalin 300 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-894 | Pregabalin 100 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-887 | Pregabalin 300 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-882 | Pregabalin 50 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-871 | Pregabalin 100 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-845 | Pregabalin 150 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-719 | Pregabalin 150 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-317 | Pregabalin 150 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-318 | Pregabalin 200 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-319 | Pregabalin 225 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-320 | Pregabalin 300 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-316 | Pregabalin 100 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-314 | Pregabalin 50 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-618 | Pregabalin 150 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-313 | Pregabalin 25 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-999 | Pregabalin 75 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-754 | Pregabalin 200 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-619 | Pregabalin 50 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 71610-677 | Pregabalin 75 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CV |
| 67877-463 | Pregabalin 50 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-464 | Pregabalin 75 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-465 | Pregabalin 100 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-462 | Pregabalin 25 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-457 | Pregabalin 20 mg/mL Solution | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-469 | Pregabalin 300 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-468 | Pregabalin 225 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-466 | Pregabalin 150 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 67877-467 | Pregabalin 200 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CV |
| 76420-095 | Pregabalin 25 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-096 | Pregabalin 50 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-097 | Pregabalin 75 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-098 | Pregabalin 100 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-099 | Pregabalin 150 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-100 | Pregabalin 200 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-101 | Pregabalin 225 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-102 | Pregabalin 300 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-124 | Pregabalin 300 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-123 | Pregabalin 225 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-122 | Pregabalin 200 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-121 | Pregabalin 150 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-120 | Pregabalin 100 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-119 | Pregabalin 75 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-118 | Pregabalin 50 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 76420-117 | Pregabalin 25 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CV |
| 65862-765 | Pregabalin 300 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-764 | Pregabalin 225 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-763 | Pregabalin 200 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-762 | Pregabalin 150 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-761 | Pregabalin 100 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-760 | Pregabalin 75 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-759 | Pregabalin 50 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 65862-758 | Pregabalin 25 mg/1 Capsule | Aurobindo Pharma Limited | ANDA · DEA CV |
| 50268-500 | Pregabalin 100 mg/1 Capsule | AvPAK | ANDA · DEA CV |
| 50268-499 | Pregabalin 75 mg/1 Capsule | AvPAK | ANDA · DEA CV |
| 50268-498 | Pregabalin 50 mg/1 Capsule | AvPAK | ANDA · DEA CV |
| 50268-497 | Pregabalin 25 mg/1 Capsule | AvPAK | ANDA · DEA CV |
| 50268-501 | Pregabalin 150 mg/1 Capsule | AvPAK | ANDA · DEA CV |
| 71335-1740 | Pregabalin 100 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1555 | Pregabalin 200 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1505 | Pregabalin 300 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1476 | Pregabalin 75 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1475 | Pregabalin 100 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1459 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1300 | Pregabalin 50 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8195 | Pregabalin 50 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8196 | Pregabalin 75 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8197 | Pregabalin 100 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8198 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8199 | Pregabalin 25 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8208 | Pregabalin 200 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8239 | Pregabalin 225 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 63629-8248 | Pregabalin 300 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1546 | Pregabalin 200 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1545 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1544 | Pregabalin 100 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1543 | Pregabalin 75 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1542 | Pregabalin 50 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1541 | Pregabalin 25 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1548 | Pregabalin 300 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-9740 | Pregabalin 300 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-9699 | Pregabalin 200 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-9671 | Pregabalin 225 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-3158 | Pregabalin 300 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-3118 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-2343 | Pregabalin 100 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-2339 | Pregabalin 75 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1822 | Pregabalin 200 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1792 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1791 | Pregabalin 25 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1790 | Pregabalin 50 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1789 | Pregabalin 100 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1788 | Pregabalin 75 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1762 | Pregabalin 25 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1758 | Pregabalin 75 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1751 | Pregabalin 50 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1745 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71335-1744 | Pregabalin 225 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-2304 | Pregabalin 150 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 72162-1547 | Pregabalin 225 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CV |
| 71209-035 | Pregabalin 100 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-036 | Pregabalin 150 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-037 | Pregabalin 200 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-038 | Pregabalin 225 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-039 | Pregabalin 300 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-034 | Pregabalin 75 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-033 | Pregabalin 50 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 71209-032 | Pregabalin 25 mg/1 Capsule | Cadila Pharmaceuticals Limited | ANDA · DEA CV |
| 31722-610 | Pregabalin 25 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-611 | Pregabalin 50 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-612 | Pregabalin 75 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-613 | Pregabalin 100 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-614 | Pregabalin 150 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-615 | Pregabalin 200 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-616 | Pregabalin 225 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 31722-617 | Pregabalin 300 mg/1 Capsule | Camber Pharmaceuticals, Inc. | ANDA · DEA CV |
| 55154-4308 | Pregabalin 100 mg/1 Capsule | Cardinal Health 107, LLC | ANDA · DEA CV |
| 55154-8097 | Pregabalin 50 mg/1 Capsule | Cardinal Health 107, LLC | ANDA · DEA CV |
| 55154-8098 | Pregabalin 75 mg/1 Capsule | Cardinal Health 107, LLC | ANDA · DEA CV |
| 62135-446 | Pregabalin 100 mg/1 Capsule | Chartwell RX, LLC | ANDA · DEA CV |
| 62135-447 | Pregabalin 150 mg/1 Capsule | Chartwell RX, LLC | ANDA · DEA CV |
| 62135-445 | Pregabalin 75 mg/1 Capsule | Chartwell RX, LLC | ANDA · DEA CV |
| 62135-444 | Pregabalin 50 mg/1 Capsule | Chartwell RX, LLC | ANDA · DEA CV |
| 69097-962 | Pregabalin 300 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-961 | Pregabalin 225 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-959 | Pregabalin 200 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-958 | Pregabalin 150 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-957 | Pregabalin 100 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-956 | Pregabalin 75 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-955 | Pregabalin 50 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 69097-954 | Pregabalin 25 mg/1 Capsule | Cipla USA, Inc. | ANDA · DEA CV |
| 58118-0761 | Pregabalin 100 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0758 | Pregabalin 25 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0759 | Pregabalin 50 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0760 | Pregabalin 75 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0762 | Pregabalin 150 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0763 | Pregabalin 200 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0764 | Pregabalin 225 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-0765 | Pregabalin 300 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-1462 | Pregabalin 25 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-1463 | Pregabalin 50 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-1464 | Pregabalin 75 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-1465 | Pregabalin 100 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-1466 | Pregabalin 150 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 58118-1467 | Pregabalin 200 mg/1 Capsule | Clinical Solutions Wholesale, LLC | ANDA · DEA CV |
| 67046-1680 | Pregabalin 25 mg/1 Capsule | Coupler LLC | ANDA · DEA CV |
| 67046-1494 | Pregabalin 50 mg/1 Capsule | Coupler LLC | ANDA · DEA CV |
| 67046-1628 | Pregabalin 100 mg/1 Capsule | Coupler LLC | ANDA · DEA CV |
| 82619-126 | Pregabalin 150 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-127 | Pregabalin 200 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-128 | Pregabalin 225 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-129 | Pregabalin 300 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-122 | Pregabalin 25 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-125 | Pregabalin 100 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-124 | Pregabalin 75 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 82619-123 | Pregabalin 50 mg/1 Capsule | Creekwood Pharmaceuticals LLC | ANDA · DEA CV |
| 72189-328 | Pregabalin 225 mg/1 Capsule | Direct Rx | ANDA · DEA CV |
| 72189-019 | Pregabalin 50 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-021 | Pregabalin 75 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-033 | Pregabalin 100 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-251 | Pregabalin 300 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-241 | Pregabalin 200 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-269 | Pregabalin 25 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-164 | Pregabalin 300 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-115 | Pregabalin 25 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 72189-045 | Pregabalin 225 mg/1 Capsule | Direct_Rx | ANDA · DEA CV |
| 43598-292 | Pregabalin 50 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-291 | Pregabalin 25 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-293 | Pregabalin 75 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-294 | Pregabalin 100 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-295 | Pregabalin 150 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-296 | Pregabalin 200 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-297 | Pregabalin 225 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 43598-298 | Pregabalin 300 mg/1 Capsule | Dr.Reddys Laboratories Inc | ANDA · DEA CV |
| 72658-0812 | Pregabalin 150 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0813 | Pregabalin 225 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0808 | Pregabalin 25 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0809 | Pregabalin 50 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0810 | Pregabalin 75 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0811 | Pregabalin 100 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0814 | Pregabalin 300 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 72658-0849 | Pregabalin 200 mg/1 Capsule | Eskayef Pharmaceuticals Limited | ANDA · DEA CV |
| 76282-574 | Pregabalin 225 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-568 | Pregabalin 25 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-569 | Pregabalin 50 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-570 | Pregabalin 75 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-571 | Pregabalin 100 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-572 | Pregabalin 150 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-573 | Pregabalin 200 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 76282-575 | Pregabalin 300 mg/1 Capsule | Exelan Pharmaceuticals Inc. | ANDA · DEA CV |
| 82968-010 | Pregabalin 150 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-011 | Pregabalin 200 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-012 | Pregabalin 225 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-013 | Pregabalin 300 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-009 | Pregabalin 100 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-008 | Pregabalin 75 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-006 | Pregabalin 25 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 82968-007 | Pregabalin 50 mg/1 Capsule | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | ANDA · DEA CV |
| 51407-574 | Pregabalin 25 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-575 | Pregabalin 50 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-576 | Pregabalin 75 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-577 | Pregabalin 100 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-578 | Pregabalin 150 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-579 | Pregabalin 200 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-580 | Pregabalin 225 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 51407-581 | Pregabalin 300 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CV |
| 14445-123 | Pregabalin 75 mg/1 Capsule | Indoco Remedies Limited | ANDA · DEA CV |
| 14445-124 | Pregabalin 100 mg/1 Capsule | Indoco Remedies Limited | ANDA · DEA CV |
Pregabalin recalls
- D-0541-2024 Jun 12, 2024 · Class III · Ongoing
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as… - D-0361-2022 Jan 12, 2022 · Class II · Terminated
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. - D-0469-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Frequently asked questions
What is Pregabalin used for?
Pregabalin is indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin is indicated for: • Neuropathic pain…
What are the side effects of Pregabalin?
The following serious adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression… See the full label for the complete list.
Who makes Pregabalin?
Pregabalin is listed by 30 labelers in the FDA NDC directory, including A-S Medication Solutions, Advagen Pharma Ltd., Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC.
Has Pregabalin been recalled?
The FDA enforcement database lists 3 recalls for Pregabalin, most recently D-0541-2024 (class iii): Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of…