Alembic Pharma's subsidiary bags USFDA final approval for Clobetasol Propionate Foam

25 Apr 2022 , 10:53 AM

Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly-owned subsidiary, Aleor Dermaceuticals Limited (Aleor) 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 the treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp parts 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.

Alembic Pharma is currently trading at Rs755.60 down by Rs10.15 or 1.33% from its previous closing of Rs765.75 on the BSE. The scrip opened at Rs760 and has touched an intraday high and low of Rs764.20 and Rs755.60 respectively.