Alembic Pharmaceuticals receives USFDA final approval for Dapsone Gel

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC.

Dapsone Gel is indicated for the topical treatment of acne vulgaris. Refer label for a detailed indication. Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.