Alembic Pharmaceuticals receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

10 Aug 2022 , 01:33 AM

Alembic Pharmaceuticals Alembic today announced that its wholly owned subsidiary Aleor Dermaceuticals Aleor 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 03Percentage25Percentage The approved ANDA is therapeutically equivalent to the reference listed drug product RLD Epiduo Forte Topical Gel 03Percentage25Percentage of Galderma Laboratories LP; Galderma Adapalene and Benzoy Peroxide Topical Gel 03Percentage25Percentage is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older Adapalene and Benzoyl Peroxide Topical Gel 03Percentage25Percentage has an estimated market size of US$211 million for twelve months ending Mar 2022 according to IQVIA Alembic has received a cumulative total of 170 ANDA approvals 146 final approvals and 24 tentative approvals from USFDA