Alembic Pharmaceuticals’ wholly owned subsidiary -- Aleor Dermaceuticals 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 $10 million for twelve months ending December 2021.
The company has received a cumulative total of 165 ANDA approvals (141 final approvals and 24 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
