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.
Read also: Alembic Pharma secures USFDA approval for Dabigatran Etexilate Capsules
