Alembic Pharma gets USFDA final nod for Dapsone Gel, 5%

Alembic Pharmaceuticals Limited has announced receiving final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%. This gel is indicated for the topical treatment of acne vulgaris and is therapeutically equivalent to Almirall, LLC's Aczone Gel, 5%. This approval adds to Alembic's portfolio, bringing their total USFDA ANDA approvals to 244, comprising 224 final and 20 tentative approvals. The company, a vertically integrated pharmaceutical entity, has a history dating back to 1907 and operates globally with manufacturing facilities approved by major regulatory bodies.