Alembic Pharmaceuticals Limited (Alembic) 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 to the label for a detailed indication.
Alembic has a cumulative total of 244 ANDA approvals (224 final and 20 tentative) from the USFDA.
