Alembic Pharma gets USFDA final nod for Efinaconazole Topical Solution

Alembic Pharmaceuticals (Alembic) received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA)
Efinaconazole Topical Solution, 10%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Efinaconazole Topical Solution, 10%, has an estimated market size of US$ 500 million for twelve months ending December 2025 according to IQVIA.