Alembic receives FDA final approval for Betamethasone Valerate Foam, 0.12%
Drug Approval

Alembic receives FDA final approval for Betamethasone Valerate Foam, 0.12%

  • By IPP Bureau | August 25, 2024

Alembic Pharmaceuticals Limited (Alembic) 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 (Norvium). 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. Refer label for a detailed indication.

Alembic has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA.

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