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

Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for antifungal drug Efinaconazole Topical Solution, 10%.

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

Alembic was one of the first applicants to submit a substantially complete ANDA with a paragraph IV certification. Efinaconazole Topical Solution, 10% had an estimated market size of $500 million for 12 months ending December 2025, the company said citing IQVIA numbers. The drug is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.