Aleor Dermaceuticals receives US FDA final approval for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%

Aleor Dermaceuticals, the wholly-owned subsidiary of Alembic Pharma, today received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%, a statement from Alembic Pharma notified.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of Galderma Laboratories, the statement said.

It further mentioned that Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and paediatric patients 12 years of age and older.