Valsartan
Tablet, Film Coated · Oral
Uses
Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 ) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Valsartan tablets may be used alone or in combination with other antihypertensive agents. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information. 1.2 Heart Failure Valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (NYHA class II-IV). There is no evidence that valsartan tablets provide added benefits when it is used with an adequate dose of an angiotensin converting enzyme (ACE) inhibitor [see Clinical Studies (14.2) ]. 1.3 Post-Myocardial Infarction In clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Valsartan tablets is indicated to reduce the risk of cardiovascular mortality [see Clinical Studies (14.3) ].
Dosage and administration
Indication Starting Dose Dose Range* Hypertension Adults (2.2 ) 80-160 mg once daily 80-320 mg once daily 6-16 years ( 2.3 ) 1 mg/kg once daily Up to 40 mg daily 1-4 mg/kg once daily Up to 160 mg daily Heart Failure ( 2.4) 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction ( 2.5 ) 20 mg twice daily 20-160 mg twice daily *As tolerated by patient 2.1 Important Dosage and Preparation Information Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets [see Clinical Pharmacology (12.3) ] . Use of the oral suspension is recommended: in patients ≥ 6 years of age who cannot swallow tablets and in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan tablets. When switching between suspension and tablets, the dose of valsartan may need to be adjusted. Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) Add 80 mL of Ora-Plus ®* oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF ®* oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2°C to 8°C/35°F to 46°F) in the glass bottle with a child-resistant screw-cap closure. Shake the bottle well (at least 10 seconds) prior to dispensing the suspension. *Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information. 2.2 Adult Hypertension The recommended starting dose of valsartan tablets is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day. The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg. Valsartan tablets may be administered with other antihypertensive agents. 2.3 Pediatric Hypertension 6 to 16 Years of Age The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total). A higher starting dose of 2 mg/kg may be considered in selected cases when a greater reduction of blood pressure is needed. The dosage should be adjusted according to blood pressure response and tolerability, up to a maximum dose of 4 mg/kg once daily (maximum daily dose 160 mg). No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate < 30 mL/min/1.73 m 2 [see Use in Specific Populations (8.4) ] . Use of valsartan tablets is not recommended in children less than 1 year of age [see Adverse Reactions (6.1) , Pediatric Use in Specific Populations (8.4) , Nonclinical Toxicology (13.2) ]. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information. 2.4 Heart Failure The recommended starting dose of valsartan is 40 mg twice daily. Uptitrate to 80 mg and 160 mg twice daily or to the highest dose tolerated by the patient. Consider reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses. 2.5 Post-Myocardial Infarction Valsartan tablets may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of valsartan tablets is 20 mg twice daily. Patients may be uptitrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consider dosage reduction. Valsartan tablets may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins. 2.6 Missed Dose If a dose of valsartan tablet is missed, it should be administered as soon as possible, unless it is almost time for the next dose. The dose should not be doubled to make up for a missed dose.
Dosage forms and strengths
Valsartan tablets, USP are available as: 40 mg tablets are yellow colored, capsule shaped, biconvex, film coated tablets, with a scoreline on one side, debossed with 'C' on one side of scoreline and 'I' on the other side of scoreline and plain on the other side. 80 mg tablets are peach colored, round, biconvex, film coated tablets, debossed with 'C3' on one side and 'C' on other side. 160 mg tablets are yellow colored, oval shaped, biconvex, film coated tablets, debossed with 'C4' on one side and 'C' on other side. 320 mg tablets are yellow colored, oval shaped, biconvex, film coated tablets, debossed with 'I' on one side and 'C' on other side. Tablets (mg): 40 (scored), 80, 160, 320 ( 3 )
Contraindications
Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes [see Drug Interactions (7.3) ]. Known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes ( 4 )
Warnings and precautions
Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan as soon as possible [see Use in Specific Populations (8.1) ]. 5.2 Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision. Patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. In the VALsartan In Acute myocardial iNfarcTion trial (VALIANT), hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients. If excessive hypotension occurs, place the patient in the supine position and, if necessary, give intravenous normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. 5.3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan [see Drug Interactions (7) ]. 5.4 Hyperkalemia Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required [see Adverse Reactions (6.1) ].
Side effects
Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine (6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with valsartan was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients. The most common reasons for discontinuation of therapy with valsartan were headache and dizziness. The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with valsartan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%). In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p <0.001). Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with valsartan 320 mg (8%) compared to 10 to 160 mg (2% to 4%). Pediatric Hypertension Valsartan has been evaluated for safety in over 400 patients aged 6 to 17 years. No relevant differences were identified between the adverse experience profile for pediatric patients and that previously reported for adult patients. Hyperkalemia was more frequently observed in pediatric patients with underlying chronic kidney disease (CKD). Heart Failure In the Valsartan Heart Failure Trial (Val-HeFT), comparing valsartan in total daily doses up to 320 mg (n=2,506) to placebo (n=2,494), 10% of valsartan patients discontinued for adverse reactions vs. 7% of placebo patients. The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients. All patients received standard drug therapy for heart failure, frequently as multiple medications, which could include diuretics, digitalis, beta-blockers. About 93% of patients received concomitant ACE inhibitors. Valsartan (n=3,282) Placebo (n=2,740) Dizziness 17% 9% Hypotension 7% 2% Diarrhea 5% 4% Arthralgia 3% 2% Fatigue 3% 2% Back Pain 3% 2% Dizziness, postural 2% 1% Hyperkalemia 2% 1% Hypotension, postural 2% 1% Discontinuations occurred in 0.5% of valsartan-treated patients and 0.1% of placebo patients for each of the following: elevations in creatinine and elevations in potassium. Other adverse reactions with an incidence greater than 1% and greater than placebo included headache, nausea, renal impairment, syncope, blurred vision, upper abdominal pain and vertigo. From the long-term data in the Valsartan Heart Failure Trial, there did not appear to be any significant adverse reactions not previously identified. Post-Myocardial Infarction The table shows the percentage of patients discontinued in the valsartan and captopril-treated groups in the VALsartan In Acute myocardial iNfarcTion trial (VALIANT) with a rate of at least 0.5% in either of the treatment groups. Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopril-treated patients. Valsartan (n=4,885) Captopril (n=4,879) Discontinuation for adverse reaction 5.8% 7.7% Adverse reactions Hypotension NOS 1.4% 0.8% Cough 0.6% 2.5% Blood creatinine increased 0.6% 0.4% Rash NOS 0.2% 0.6% Clinical Laboratory Test Findings Creatinine: In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients. In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients. Neutropenia: Neutropenia was observed in 1.9% of patients treated with valsartan and 0.8% of patients treated with placebo. Blood Urea Nitrogen (BUN): In heart failure trials, greater than 50% increases in BUN were observed in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients [see Warnings and Precautions (5.3)] . Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that information.
Drug interactions
Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine (7.1) Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ) Dual inhibition of the Renin-Angiotensin System (RAS): Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ) Lithium: Increases in serum lithium level and lithium toxicity ( 7.4 ) 7.1 Agents Increasing Serum Potassium Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. 7.2 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. 7.3 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy [see Clinical Studies (14.3) ] . In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS. Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR <60 mL/min). 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
Use in specific populations
Lactation : Breastfeeding is not recommended ( 8.2 ) Pediatrics : Use of valsartan tablets is not recommended in children less than 1 year of age ( 6.1 , 8.4 , 13.2 ) Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information. 8.1 Pregnancy Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations ) . When pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is 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 Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking valsartan during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia . In neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data No teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (MRHD) on a mg/m 2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day. In rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. In rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. 8.2 Lactation Risk Summary There is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan. Data Valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. 8.4 Pediatric Use The antihypertensive effects of valsartan have been evaluated in a clinical study in pediatric patients from 6-16 years of age [see Clinical Studies (14.1) ]. The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology (12.3) ] . The adverse experience profile of valsartan was similar to that described for adults [see Adverse Reactions (6.1) ]. In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. Use of valsartan tablet is not recommended in children less than 1 year of age [see Nonclinical Toxicology (13.2) ] . It is not known whether post-natal use of valsartan, before maturation of renal function is complete, has a long-term deleterious effect on the kidney. No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min/1.73 m 2 . Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information. 8.5 Geriatric Use In the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥65 years and 265 (7.9%) were ≥75 years.
Pregnancy
8.1 Pregnancy Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations ) . When pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is 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 Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking valsartan during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia . In neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data No teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (MRHD) on a mg/m 2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day. In rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. In rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed.
Pediatric use
8.4 Pediatric Use The antihypertensive effects of valsartan have been evaluated in a clinical study in pediatric patients from 6-16 years of age [see Clinical Studies (14.1) ]. The pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology (12.3) ] . The adverse experience profile of valsartan was similar to that described for adults [see Adverse Reactions (6.1) ]. In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. Use of valsartan tablet is not recommended in children less than 1 year of age [see Nonclinical Toxicology (13.2) ] . It is not known whether post-natal use of valsartan, before maturation of renal function is complete, has a long-term deleterious effect on the kidney. No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min/1.73 m 2 . Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information.
Geriatric use
8.5 Geriatric Use In the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥65 years and 265 (7.9%) were ≥75 years. No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. Exposure [measured by area under the curve (AUC)] to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary [see Clinical Pharmacology (12.3) ]. Of the 2,511 patients with heart failure randomized to valsartan in the Valsartan Heart Failure Trial, 45% (1,141) were 65 years of age or older. In the VALsartan In Acute myocardial iNfarcTion trial (VALIANT), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. There were no notable differences in efficacy or safety between older and younger patients in either trial.
Overdosage
Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, institute supportive treatment. Valsartan is not removed from the plasma by hemodialysis. Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the MRHD dose on a mg/m 2 basis) (Calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Description
Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.52, and its structural formula is: Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP. structuralformula
Mechanism of action
12.1 Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT 1 receptor than for the AT 2 receptor. The increased plasma levels of angiotensin II following AT 1 receptor blockade with valsartan may stimulate the unblocked AT 2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT 1 receptor about one-200 th (1/200 th ) that of valsartan itself. Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.
How supplied
Valsartan Tablets, USP are available as follows: 40 mg tablets are yellow, capsule shaped, biconvex, film-coated with a functional score line on one side, debossed with 'C' on one side of score line and 'I' on other side of score line and plain on the other side. Bottle of 30’s (child-resistant closure) 59746-360-30 Bottle of 90’s (child-resistant closure) 59746-360-90 Bottle of 500’s 59746-360-05 Carton of 10x10’s 59746-360-03 80 mg tablets are peach, round, biconvex, film-coated, debossed with 'C3' on one side and 'C' on other side. Bottle of 30’s (child-resistant closure) 59746-361-30 Bottle of 90’s (child-resistant closure) 59746-361-90 Bottle of 500’s 59746-361-05 Carton of 10x10’s 59746-361-03 160 mg tablets are yellow, oval shaped, biconvex, film-coated, debossed with 'C4' on one side and 'C' on the other side. Bottle of 30’s (child-resistant closure) 59746-362-30 Bottle of 90’s (child-resistant closure) 59746-362-90 Bottle of 500’s 59746-362-05 Carton of 10x10’s 59746-362-03 320 mg tablets are yellow, oval shaped, biconvex, film-coated, debossed with 'I' on one side and 'C' on the other side. Bottle of 30’s (child-resistant closure) 59746-393-30 Bottle of 90’s (child-resistant closure) 59746-393-90 Bottle of 400’s 59746-393-67 Carton of 3x10’s 59746-393-32 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy : Advise female patients of childbearing age about the consequences of exposure to valsartan during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their healthcare provider as soon as possible [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ] . Lactation : Advise women not to breastfeed during treatment with valsartan [see Use in Specific Populations (8.2) ]. Symptomatic Hypotension : Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue valsartan until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions (5.2) ] . Hyperkalemia : Advise patients not to use salt substitutes without consulting their healthcare provider [see Drug Interactions (7.1) ] . All brands mentioned are trademarks of their respective owners and are not trademarks of Jubilant Generics Limited. Rx Only Made in India Marketed by: Jubilant Cadista Pharmaceuticals Inc. Yardley, PA 19067, USA Revised: 08/2026
Label text from the FDA structured product label by Jubilant Cadista Pharmaceuticals Inc. (revised Aug 26, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Valsartan in 132 products
Valsartan NDC products (132)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7312 | Valsartan 320 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6348 | Valsartan 160 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6347 | Valsartan 80 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6346 | Valsartan 320 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5192 | Valsartan 320 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5191 | Valsartan 160 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5190 | Valsartan 80 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4130 | Valsartan 320 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2424 | Valsartan 80 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 72888-184 | Valsartan 4 mg/mL Solution | Advagen Pharma Ltd | ANDA |
| 62332-044 | Valsartan 40 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-045 | Valsartan 80 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-046 | Valsartan 160 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-047 | Valsartan 320 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-047 | Valsartan 320 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-044 | Valsartan 40 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-045 | Valsartan 80 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-046 | Valsartan 160 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 60687-634 | Valsartan 160 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-623 | Valsartan 80 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-612 | Valsartan 40 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 65162-837 | Valsartan 40 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-838 | Valsartan 80 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-839 | Valsartan 160 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-840 | Valsartan 320 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 53746-837 | Valsartan 40 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-838 | Valsartan 80 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-840 | Valsartan 320 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-839 | Valsartan 160 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 70954-310 | Valsartan 4 mg/mL Solution | ANI Pharmaceuticals, Inc. | ANDA |
| 53401-033 | Valsartan 40 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-029 | Valsartan 80 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-418 | Valsartan 320 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-417 | Valsartan 160 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-416 | Valsartan 80 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-415 | Valsartan 40 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 65862-571 | Valsartan 80 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-570 | Valsartan 40 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-572 | Valsartan 160 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-573 | Valsartan 320 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 42291-858 | Valsartan 160 mg/1 Tablet | AvKARE | ANDA |
| 42291-856 | Valsartan 40 mg/1 Tablet | AvKARE | ANDA |
| 42291-857 | Valsartan 80 mg/1 Tablet | AvKARE | ANDA |
| 42291-859 | Valsartan 320 mg/1 Tablet | AvKARE | ANDA |
| 50268-749 | Valsartan 320 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-748 | Valsartan 160 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-747 | Valsartan 80 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 50268-746 | Valsartan 40 mg/1 Tablet, Film Coated | AvPAK | ANDA |
| 71335-0475 | Valsartan 320 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0567 | Valsartan 80 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1337 | Valsartan 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-3165 | Valsartan 80 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2155 | Valsartan 320 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2154 | Valsartan 160 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2308 | Valsartan 40 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2248 | Valsartan 160 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2152 | Valsartan 80 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2151 | Valsartan 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 31722-153 | Valsartan 160 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-154 | Valsartan 320 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-745 | Valsartan 40 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-746 | Valsartan 80 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-747 | Valsartan 160 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-748 | Valsartan 320 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-151 | Valsartan 40 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-152 | Valsartan 80 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 67046-1574 | Valsartan 320 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1596 | Valsartan 80 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72189-550 | Valsartan 80 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-049 | Valsartan 80 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 55111-731 | Valsartan 40 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-732 | Valsartan 80 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-733 | Valsartan 160 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-734 | Valsartan 320 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 59746-360 | Valsartan 40 mg/1 Tablet | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 59746-361 | Valsartan 80 mg/1 Tablet | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 59746-362 | Valsartan 160 mg/1 Tablet | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 59746-393 | Valsartan 320 mg/1 Tablet | Jubilant Cadista Pharmaceuticals Inc. | ANDA |
| 42385-992 | Valsartan 320 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 42385-989 | Valsartan 40 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 42385-990 | Valsartan 80 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 42385-991 | Valsartan 160 mg/1 Tablet, Film Coated | Laurus Labs Limited | ANDA |
| 72336-910 | Valsartan 4 mg/mL Solution | Lifsa Drugs LLC | ANDA |
| 68180-276 | Valsartan 40 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-065 | Valsartan 320 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-064 | Valsartan 160 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-063 | Valsartan 80 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-062 | Valsartan 40 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 0378-5813 | Valsartan 80 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-5807 | Valsartan 40 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-5814 | Valsartan 160 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-5815 | Valsartan 320 mg/1 Tablet, Film Coated | Mylan Pharmaceuticals Inc. | ANDA |
| 82868-011 | Valsartan 160 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 82868-010 | Valsartan 80 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-834 | Valsartan 160 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-695 | Valsartan 160 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-653 | Valsartan 80 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-456 | Valsartan 160 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-244 | Valsartan 160 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51660-143 | Valsartan 320 mg/1 Tablet, Film Coated | Ohm Laboratories Inc. | ANDA |
| 51660-142 | Valsartan 160 mg/1 Tablet, Film Coated | Ohm Laboratories Inc. | ANDA |
| 51660-140 | Valsartan 40 mg/1 Tablet, Film Coated | Ohm Laboratories Inc. | ANDA |
| 51660-141 | Valsartan 80 mg/1 Tablet, Film Coated | Ohm Laboratories Inc. | ANDA |
| 72789-281 | Valsartan 160 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-553 | Valsartan 40 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 63187-655 | Valsartan 320 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-154 | Valsartan 160 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-301 | Valsartan 320 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 50228-132 | Valsartan 320 mg/1 Tablet | ScieGen Pharmaceuticals, INC. | ANDA |
| 50228-133 | Valsartan 160 mg/1 Tablet | ScieGen Pharmaceuticals, INC. | ANDA |
| 50228-134 | Valsartan 80 mg/1 Tablet | ScieGen Pharmaceuticals, INC. | ANDA |
| 50228-135 | Valsartan 40 mg/1 Tablet | ScieGen Pharmaceuticals, INC. | ANDA |
| 43547-370 | Valsartan 320 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-369 | Valsartan 160 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-368 | Valsartan 80 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-367 | Valsartan 40 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 76483-025 | Valsartan 320 mg/1 Tablet | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 76483-024 | Valsartan 160 mg/1 Tablet | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 76483-023 | Valsartan 80 mg/1 Tablet | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 76483-026 | Valsartan 40 mg/1 Tablet | SQUARE PHARMACEUTICALS LIMITED | ANDA |
| 29300-232 | Valsartan 40 mg/1 Tablet, Film Coated | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-233 | Valsartan 80 mg/1 Tablet, Film Coated | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-234 | Valsartan 160 mg/1 Tablet, Film Coated | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-235 | Valsartan 320 mg/1 Tablet, Film Coated | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 72578-133 | Valsartan 160 mg/1 Tablet, Film Coated | Viona Pharmaceuticals Inc | ANDA |
| 72578-134 | Valsartan 320 mg/1 Tablet, Film Coated | Viona Pharmaceuticals Inc | ANDA |
| 72578-132 | Valsartan 80 mg/1 Tablet, Film Coated | Viona Pharmaceuticals Inc | ANDA |
| 72578-131 | Valsartan 40 mg/1 Tablet, Film Coated | Viona Pharmaceuticals Inc | ANDA |
| 70771-1882 | Valsartan 40 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1883 | Valsartan 80 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1885 | Valsartan 320 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1884 | Valsartan 160 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
Valsartan recalls
- D-0461-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-1039-2019 Mar 27, 2019 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-1038-2019 Mar 27, 2019 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-1037-2019 Mar 27, 2019 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-1035-2019 Mar 27, 2019 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0370-2019 Jan 23, 2019 · Class II · Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - D-0324-2019 Dec 19, 2018 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0325-2019 Dec 19, 2018 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0326-2019 Dec 19, 2018 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0327-2019 Dec 19, 2018 · Class II · Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - D-0316-2019 Dec 19, 2018 · Class II · Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0315-2019 Dec 19, 2018 · Class II · Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0314-2019 Dec 19, 2018 · Class II · Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-0313-2019 Dec 19, 2018 · Class II · Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - D-1115-2018 Aug 29, 2018 · Class II · Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-1114-2018 Aug 29, 2018 · Class II · Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-1113-2018 Aug 29, 2018 · Class II · Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - D-1105-2018 Aug 29, 2018 · Class III · Terminated
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. - D-1104-2018 Aug 29, 2018 · Class III · Terminated
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. - D-1116-2018 Aug 29, 2018 · Class II · Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Frequently asked questions
What is Valsartan used for?
Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 )…
What are the side effects of Valsartan?
Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased… See the full label for the complete list.
Who makes Valsartan?
Valsartan is listed by 34 labelers in the FDA NDC directory, including A-S Medication Solutions, Advagen Pharma Ltd, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Valsartan been recalled?
The FDA enforcement database lists 20 recalls for Valsartan, most recently D-0461-2021 (class ii): CGMP Deviations: Intermittent exposure to temperature excursion during storage.