Aleor Derma gets USFDA nod for Clobetasol Propionate Foam
Clobetasol Propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp.
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company's wholly-owned subsidiary, Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Olux Foam, 0.05%, of Mylan Pharmaceuticals Inc.
Clobetasol Propionate Foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and Older.
Clobetasol Propionate Foam, 0.05% has an estimated market size of US$10 million for twelve months ending Dec 2021 according to IQVIA.
Alembic has received a cumulative total of 165 ANDA approvals (141 final approvals and 24 tentative approvals) from USFDA.
Read also: Alembic Pharma gets USFDA nod for heart failure drug lvabradine
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: Alembic Pharma arm gets USFDA nod for Lidocaine and Prilocaine Cream
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.