Alembic Pharma wins USFDA okay for Betamethasone Valerate Foam
Vadodara: Alembic Pharmaceuticals Limited today announced that the Company 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.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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