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.
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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.
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