Alembic Pharma gets U.S. FDA nod for generic antifungal drug

Alembic Pharmaceuticals has received last support from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated caller cause exertion for antifungal cause Efinaconazole Topical Solution, 10%.

The approved ANDA is therapeutically equivalent to Jublia Topical Solution, 10%, of Bausch Health Americas, Inc.

Alembic was 1 of the archetypal applicants to taxable a substantially implicit ANDA with a paragraph IV certification. Efinaconazole Topical Solution, 10% had an estimated marketplace size of $500 cardinal for 12 months ending December 2025, the institution said citing IQVIA numbers. The cause is indicated for the topical attraction of onychomycosis of the toenail(s) owed to Trichophyton rubrum and Trichophyton mentagrophytes.