Alembic Wins FDA Approval For Betamethasone Foam

Alembic Pharmaceuticals Limited (Alembic) has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Valerate Foam, 0.12%. This newly approved ANDA is a therapeutic equivalent to Luxiq Foam, 0.12%, the reference listed drug (RLD) produced by Norvium Bioscience, LLC.

Betamethasone Valerate Foam, 0.12% is classified as a medium-potency topical corticosteroid, prescribed to alleviate inflammation and itching associated with corticosteroid-responsive dermatoses of the scalp. For detailed usage instructions, please refer to the product label. With this approval, Alembic now has a total of 213 ANDA approvals from the USFDA, comprising 185 final approvals and 28 tentative approvals.