Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for the generic version of Dapsone gel indicated for the topical treatment of acne vulgaris.
The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dapsone gel, 5 per cent, Alembic Pharmaceuticals said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5 per cent of Almirall, LLC, it added.
Dapsone gel is indicated for the topical treatment of acne vulgaris, the company said.