Alembic Pharmaceuticals Limited on Monday 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%.
According to the company’s press statement, 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 Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age 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 March 2022. The company also claimed that Alembic has received a cumulative total of 170 ANDA approvals (146 final approvals and 24 tentative approvals) from USFDA.