Insight Online News
Mumbai, Aug 8 : Alembic Pharmaceuticals on Monday said its wholly owned subsidiary, Aleor Dermaceuticals 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.
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.
Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% has an estimated market size of of $211 million for twelve months ending Mar 2022 according to IQVIA.