Alembic Wins FDA Approval For Betamethasone Foam
Alembic gets USFDA approval for Betamethasone Valerate Foam, expanding its topical corticosteroid portfolio.
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.
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