Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10 per cent.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Jublia Topical Solution, 10 per cent, of Bausch Health Americas, Inc. Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) caused by Trichophyton rubrum and Trichophyton mentagrophytes. Refer to the label for detailed indication.
Alembic was among the first ANDA applicants to submit a substantially complete application with a paragraph IV certification.
Efinaconazole Topical Solution, 10 per cent, has an estimated market size of US$ 500 million for the twelve months ending December 2025, according to IQVIA.
With this approval, Alembic now has a cumulative total of 234 ANDA approvals from the USFDA, comprising 215 final approvals and 19 tentative approvals.