Alembic Pharmaceuticals Limited (Alembic) today announced that it has 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. Refer label for a detailed indication.
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 USD 500 million for twelve months ending December 2025 according to IQVIA.
Alembic has a cumulative total of 234 ANDA approvals (215 final approvals and 19 tentative approvals) from USFDA
