Clobetasol Propionate
Clobetasol Propionate Ointment USP, 0.05% · Ointment · Topical, Ophthalmic
Uses
1 INDICATIONS AND USAGE BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery. BYQLOVI is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )
Dosage and administration
Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2.1 ) Wash hands well before each use. ( 2.2 ) 2.1 Recommended Dosage Instill one drop of BYQLOVI into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. 2.2 Administration Instructions Wash hands well before each use. If using other eye drops in addition to BYQLOVI, wait at least 5 minutes between instillation of BYQLOVI and other eye drops.
Dosage forms and strengths
Ophthalmic suspension containing clobetasol propionate 0.05% (0.5 mg/mL). Ophthalmic suspension containing clobetasol propionate 0.05%. ( 3 )
Contraindications
4 CONTRAINDICATIONS BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. BYQLOVI is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ( 4 )
Warnings and precautions
Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts : Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 ) Corneal and Scleral Melting : In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. ( 5.4 ) Bacterial Infections : Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. ( 5.5 ) Viral Infections : Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.6 ) Fungal Infections : Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. ( 5.7 ) 5.1 Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If BYQLOVI is used for 10 days or longer, IOP should be monitored. 5.2 Cataracts Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 Delayed Healing The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. 5.4 Corneal and Scleral Melting In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining . 5.5 Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. 5.6 Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). 5.7 Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal culture should be taken when appropriate. 5.8 Risk of Contamination Do not allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension. 5.9 Contact Lens Wear BYQLOVI should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of BYQLOVI. The preservative in BYQLOVI may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes following administration of BYQLOVI.
Side effects
The following serious reactions are found elsewhere in the labeling: Intraocular Pressure (IOP) Increase [see Warnings and Precautions (5.1) ] Posterior Subcapsular Cataract Formation [see Warnings and Precautions (5.2) ] Delayed Healing [see Warnings and Precautions (5.3) ] Corneal and Scleral Melting [see Warnings and Precautions (5.4) ] Bacterial Infections [see Warnings and Precautions (5.5) ] Viral Infections [see Warnings and Precautions (5.6) ] Fungal Infections [see Warnings and Precautions (5.7) ] Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). Many of these reactions may have been the consequence of the surgical procedure ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. at 1-833-393-6684 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. Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received BYQLOVI included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). Many of these reactions may have been the consequence of the surgical procedure.
Use in specific populations
8.1 Pregnancy Risk Summary There are no adequate and well-controlled clinical studies of BYQLOVI administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of BYQLOVI [see Clinical Pharmacology (12.3) ] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data ) . BYQLOVI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg. Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption. In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption. 8.2 Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in human milk, the effects on the breastfed infant, or the effects on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. However, systemic levels of clobetasol propionate following topical ocular administration are minimal [see Clinical Pharmacology (12.3) ], and it is not known whether measurable levels of clobetasol propionate would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BYQLOVI, and any potential adverse effects on the breastfed infant from BYQLOVI. 8.4 Pediatric Use The safety and effectiveness of BYQLOVI in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety and effectiveness of BYQLOVI have been observed between patients 65 years of age and older and younger adult patients.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled clinical studies of BYQLOVI administration in pregnant women to inform drug-associated risks. Plasma concentrations of clobetasol propionate were minimal following topical ophthalmic administration of BYQLOVI [see Clinical Pharmacology (12.3) ] . However, corticosteroids, including clobetasol propionate have been shown to be teratogenic and fetotoxic in laboratory animals when administered systemically at relatively low dosage levels (see Data ) . BYQLOVI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies in mice, clobetasol propionate was fetotoxic at the highest subcutaneous dose tested (1 mg/kg) and teratogenic at all subcutaneous dose levels tested down to 0.03 mg/kg. Abnormalities observed included cleft palate and skeletal abnormalities. These doses are approximately 98 times and 3 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption. In embryofetal development studies in rabbits, clobetasol propionate was teratogenic at subcutaneous doses of 3 and 10 µg/kg. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. These doses are approximately 1.2 times and 3.9 times, respectively, the recommended human ophthalmic dose of BYQLOVI, estimated based on body surface area and assuming 100% systemic absorption.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of BYQLOVI in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use No overall differences in safety and effectiveness of BYQLOVI have been observed between patients 65 years of age and older and younger adult patients.
Description
(clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 CIFO 5 and a molecular weight of 467. BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use. Each mL of BYQLOVI contains: ACTIVE: clobetasol propionate 0.5 mg (0.05%) INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection PRESERVATIVE: benzalkonium chloride 0.0036%. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .
How supplied
16.1 How Supplied BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% (0.5 mg/mL) is a sterile ophthalmic suspension. It is supplied in a multi-dose white low-density polyethylene plastic 5 mL eye-dropper bottle with a low-density polyethylene white tip and a high-density polyethylene pink cap with a tamper-proof ring at the bottom of the cap. 3.5 mL in a 5 mL bottle (NDC 81046-0319-1) 16.2 Storage and Handling Do not use if tamper-evident ring seal is broken. Keep the bottle tightly closed with the pink cap when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, BYQLOVI can be used until the expiration date on the bottle.
Storage
16.2 Storage and Handling Do not use if tamper-evident ring seal is broken. Keep the bottle tightly closed with the pink cap when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze. After opening, BYQLOVI can be used until the expiration date on the bottle.
Patient information
Administration with Other Eye Drops Advise patients to wait at least 5 minutes between instillation of BYQLOVI and other eye drops if using other eye drops in addition to BYQLOVI. Risk of Contamination Advise patients to wash their hands well before each use. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the ophthalmic suspension. When to Seek Physician Advice Advise patients to consult a physician if pain develops; or if redness, itching, or inflammation becomes aggravated. Contact Lens Wear Advise patients that the preservative in BYQLOVI may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of BYQLOVI and may be reinserted after 15 minutes following administration.
Label text from the FDA structured product label by Eyenovia, Inc. (revised Apr 16, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Clobetasol Propionate in 105 products
Clobetasol Propionate NDC products (105)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0549 | Clobetasol Propionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-5079 | Clobetasol Propionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-5264 | Clobetasol Propionate .5 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-5488 | Clobetasol Propionate .5 mg/g Ointment | A-S Medication Solutions | ANDA |
| 50090-5778 | Clobetasol Propionate .4625 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-6402 | Clobetasol Propionate .5 mg/g Ointment | A-S Medication Solutions | ANDA |
| 50090-8001 | Clobetasol Propionate .5 mg/g Ointment | A-S Medication Solutions | ANDA |
| 50090-6731 | Clobetasol Propionate .5 mg/g Ointment | A-S Medication Solutions | ANDA |
| 50090-6717 | Clobetasol Propionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 0472-0404 | Clobetasol Propionate .05 g/100mL Lotion | Actavis Pharma, Inc. | ANDA |
| 62332-425 | Clobetasol Propionate .05 g/mL Spray | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-707 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-548 | Clobetasol Propionate .05 g/100mL Shampoo | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-547 | Clobetasol Propionate .5 mg/g Cream | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-486 | Clobetasol Propionate .5 mg/mL Solution | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-465 | Clobetasol Propionate .5 mg/g Ointment | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-465 | Clobetasol Propionate .5 mg/g Ointment | Alembic Pharmaceuticals Limited | ANDA |
| 46708-486 | Clobetasol Propionate .5 mg/mL Solution | Alembic Pharmaceuticals Limited | ANDA |
| 46708-425 | Clobetasol Propionate .05 g/mL Spray | Alembic Pharmaceuticals Limited | ANDA |
| 46708-547 | Clobetasol Propionate .5 mg/g Cream | Alembic Pharmaceuticals Limited | ANDA |
| 46708-548 | Clobetasol Propionate .05 g/100mL Shampoo | Alembic Pharmaceuticals Limited | ANDA |
| 46708-707 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Alembic Pharmaceuticals Limited | ANDA |
| 69238-1532 | Clobetasol Propionate .5 mg/g Cream | Amneal Pharmaceuticals LLC | ANDA |
| 69238-1732 | Clobetasol Propionate .05 g/100mL Shampoo | Amneal Pharmaceuticals NY LLC | ANDA |
| 59651-732 | Clobetasol Propionate .5 mg/g Ointment | Aurobindo Pharma Limited | ANDA |
| 42291-077 | Clobetasol Propionate .5 mg/g Ointment | AvKARE | ANDA |
| 42291-076 | Clobetasol Propionate .5 mg/g Cream | AvKARE | ANDA |
| 63629-2456 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 72162-1961 | Clobetasol Propionate .5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 72162-1442 | Clobetasol Propionate .05 g/100mL Shampoo | Bryant Ranch Prepack | ANDA |
| 72162-1438 | Clobetasol Propionate .5 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 72162-1273 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-2329 | Clobetasol Propionate .5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-2330 | Clobetasol Propionate .5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-2331 | Clobetasol Propionate .5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-2332 | Clobetasol Propionate .5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 71335-2860 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 71335-2859 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 71335-2851 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 71335-2837 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-9461 | Clobetasol Propionate .05 g/100mL Shampoo | Bryant Ranch Prepack | ANDA |
| 63629-9460 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Bryant Ranch Prepack | ANDA |
| 63629-8639 | Clobetasol Propionate .5 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-8638 | Clobetasol Propionate .5 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-8637 | Clobetasol Propionate .5 mg/g Gel | Bryant Ranch Prepack | ANDA |
| 63629-2458 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-2457 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-2455 | Clobetasol Propionate .5 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 0713-0656 | Clobetasol Propionate .5 mg/g Ointment | Cosette Pharmaceuticals, Inc. | ANDA |
| 72189-262 | Clobetasol Propionate .5 mg/g Cream | DIRECT RX | ANDA |
| 0168-0163 | Clobetasol Propionate .5 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA |
| 0168-0162 | Clobetasol Propionate .5 mg/g Ointment | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA |
| 0168-0293 | Clobetasol Propionate .5 mg/g Gel | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA |
| 0168-0269 | Clobetasol Propionate .5 mg/mL Solution | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 21922-017 | Clobetasol Propionate .5 mg/g Ointment | Encube Ethicals, Inc. | ANDA |
| 21922-061 | Clobetasol Propionate .5 mg/mL Solution | Encube Ethicals, Inc. | ANDA |
| 68462-529 | Clobetasol Propionate .5 mg/g Cream | Glenmark Pharmaceutcials Inc., USA | ANDA |
| 68462-625 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-608 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-532 | Clobetasol Propionate .5 mg/mL Solution | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-530 | Clobetasol Propionate .5 mg/g Ointment | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-480 | Clobetasol Propionate .05 g/mL Spray | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 51407-737 | Clobetasol Propionate .5 mg/mL Solution | Golden State Medical Supply, Inc. | ANDA |
| 68180-536 | Clobetasol Propionate .05 g/100mL Lotion | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-956 | Clobetasol Propionate .5 mg/g Cream | Lupin Pharmaceuticals, Inc. | ANDA |
| 43386-096 | Clobetasol Propionate .5 mg/g Ointment | Lupin Pharmaceuticals,Inc. | ANDA |
| 43386-028 | Clobetasol Propionate .5 mg/mL Solution | Lupin Pharmaceuticals,Inc. | ANDA |
| 33342-326 | Clobetasol Propionate .5 mg/mL Spray | Macleods Pharmaceuticals Limited | ANDA |
| 33342-321 | Clobetasol Propionate .4625 mg/mL Solution | Macleods Pharmaceuticals Limited | ANDA |
| 33342-506 | Clobetasol Propionate .5 mg/g Ointment | Macleods Pharmaceuticals Limited | ANDA |
| 42571-362 | Clobetasol Propionate .5 mg/mL Solution | Micro Labs Limited | ANDA |
| 16714-782 | Clobetasol Propionate .5 mg/g Ointment | Northstar Rx LLC | ANDA |
| 16714-030 | Clobetasol Propionate .05 g/100mL Shampoo | NORTHSTAR RX LLC | ANDA |
| 72603-855 | Clobetasol Propionate .5 mg/g Ointment | NorthStar RxLLC | ANDA |
| 40032-028 | Clobetasol Propionate .5 mg/mL Solution | Novel Laboratories, Inc. | ANDA |
| 40032-096 | Clobetasol Propionate .5 mg/g Ointment | Novel Laboratories, Inc. | ANDA |
| 68071-3922 | Clobetasol Propionate .5 mg/g Ointment | NuCare Pharmaceuticals, Inc. | ANDA |
| 45802-437 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-637 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-925 | Clobetasol Propionate .5 mg/g Gel | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-961 | Clobetasol Propionate .05 g/100mL Shampoo | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 68788-7963 | Clobetasol Propionate .5 mg/g Ointment | Preferred Pharmaceuticals Inc. | ANDA |
| 82804-083 | Clobetasol Propionate .5 mg/g Cream | Proficient Rx LP | ANDA |
| 70752-153 | Clobetasol Propionate .5 mg/mL Solution | Quagen Pharmaceuticals LLC | ANDA |
| 51672-1293 | Clobetasol Propionate .5 mg/mL Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4193 | Clobetasol Propionate .5 mg/g Aerosol, Foam | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1371 | Clobetasol Propionate .05 g/mL Spray | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1350 | Clobetasol Propionate .5 mg/mL Lotion | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1347 | Clobetasol Propionate .05 g/100mL Shampoo | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1297 | Clobetasol Propionate .5 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1294 | Clobetasol Propionate .5 mg/g Gel | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1259 | Clobetasol Propionate .5 mg/g Ointment | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-1258 | Clobetasol Propionate .5 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 13668-569 | Clobetasol Propionate .5 mg/g Cream | Torrent Pharmaceuticals Limited | ANDA |
| 72578-085 | Clobetasol Propionate .05 g/100mL Lotion | Viona Pharmaceuticals Inc | ANDA |
| 70700-109 | Clobetasol Propionate .5 mg/g Cream | Xiromed, LLC | ANDA |
| 70700-106 | Clobetasol Propionate .5 mg/g Ointment | Xiromed, LLC | ANDA |
| 70771-1498 | Clobetasol Propionate .05 g/100mL Lotion | Zydus Lifesciences Limited | ANDA |
| 70771-1209 | Clobetasol Propionate .5 mg/g Ointment | Zydus Lifesciences Limited | ANDA |
| 70771-1080 | Clobetasol Propionate .05 g/mL Spray | Zydus Lifesciences Limited | ANDA |
| 68382-998 | Clobetasol Propionate .05 g/mL Spray | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1401 | Clobetasol Propionate .5 mg/g Ointment | Zydus Pharmaceuticals USA Inc. | ANDA |
| 81046-0319 | Clobetasol Propionate .5 mg/mL Suspension/ Drops | Eyenovia, Inc. | NDA |
| 74157-710 | Clobetasol Propionate .25 mg/g Cream | INA Pharmaceutics Inc | NDA AUTHORIZED GENERIC |
| 68308-664 | Clobetasol Propionate .05 g/100mL Shampoo | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC |
Clobetasol Propionate recalls
- D-0789-2026 Sep 2, 2026 · Class II · Ongoing
Failed content uniformity specifications. - D-0174-2023 Feb 1, 2023 · Class III · Terminated
Subpotent Drug: Low assay result observed during long-term stability testing. - D-0375-2022 Jan 19, 2022 · Class I · Terminated
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria - D-0618-2020 Dec 18, 2019 · Class III · Terminated
Defective delivery system; product is not foaming or is coming out as liquid. - D-0619-2020 Dec 18, 2019 · Class III · Terminated
Defective delivery system; product is not foaming or is coming out as liquid. - D-0492-2019 Feb 20, 2019 · Class III · Terminated
Defective Container; complaints of leakage. - D-0249-2018 Feb 7, 2018 · Class III · Terminated
Failed Content Uniformity Specifications - D-0945-2017 Jul 12, 2017 · Class III · Terminated
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Frequently asked questions
What is Clobetasol Propionate used for?
1 INDICATIONS AND USAGE BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery. BYQLOVI is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )
What are the side effects of Clobetasol Propionate?
The following serious reactions are found elsewhere in the labeling: Intraocular Pressure (IOP) Increase [see Warnings and Precautions (5.1) ] Posterior Subcapsular Cataract Formation [see Warnings and Precautions (5.2) ] Delayed Healing [see Warnings and Precautions (5.3) ] Corneal and Scleral Melting [see Warnings and Precautions (5.4) ] Bacterial Infections [see Warnings and Precautions (5.5)… See the full label for the complete list.
Who makes Clobetasol Propionate?
Clobetasol Propionate is listed by 39 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Clobetasol Propionate been recalled?
The FDA enforcement database lists 8 recalls for Clobetasol Propionate, most recently D-0789-2026 (class ii): Failed content uniformity specifications.