Alembic Pharmaceuticals Receives USFDA Final Approval for Betamethasone Valerate Foam, 0.12%

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Luxiq Foam, 0.12%, of Norvium Bioscience, LLC. Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Alembic has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA. The company is a publicly listed research and development pharmaceutical company, headquartered in India, with state of the art research and manufacturing facilities approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India, with a marketing team of over 5000 and brands well recognized by doctors and patients.