Alembic Pharmaceuticals 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.
Alembic has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1783.55 |
| Dr. Reddys Lab | 1277.80 |
| Cipla | 1400.70 |
| Zydus Lifesciences | 1088.90 |
| Lupin | 2268.10 |
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