Aleor Dermaceuticals bags USFDA final approval for Adapalene and Benzoyl Peroxide Topical Gel

8 Aug 2022 , 02:01 PM

Alembic Pharmaceuticals Limited on Monday has announced that its 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 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. 

As per the press release, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of Galderma Laboratories, L.P; (Galderma).

Adapalene and BenzoyI Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients of 12 years and older.

according to IQVIA, Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% has an estimated market size of US$211 million for twelve months ending Mar 2022.

Alembic has received a cumulative total of 170 ANDA approvals includes 146 final approvals and 24 tentative approvals) from USFDA.

At around 2:03 PM, Alembic Pharmaceuticals was trading at Rs667 per share down by Rs5.65 or 0.84% from its previous closing of Rs672.65 per share on the BSE.