Alembic Pharmaceuticals on Monday said its wholly-owned arm, Aleor Dermaceuticals has received final approval from the US health regulator for its generic Clobetasol Propionate foam indicated for the treatment of plaque psoriasis.
The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Clobetasol Propionate foam, 0.05 per cent, Alembic said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Olux Foam, 0.05 per cent, of Mylan Pharmaceuticals Inc,it added.
The company said Clobetasol Propionate foam is a corticosteroid indicated for the 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.
Citing IQVIA data, Alembic said Clobetasol Propionate foam, 0.05 per cent had an estimated market size of $10 million for 12 months ended December 2021.
The company said it has so far received total 165 ANDA approvals (141 final approvals and 24 tentative approvals) from USFDA.
