Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tavaborole Topical Solution, 5%.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Kerydin Topical Solution, 5%, of Anacor Pharmaceuticals.
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Tavaborole Topical Solution, 5% has an estimated market size of $ 82 million for twelve months ending June 2020 according to IQVIA. Alembic is currently in litigation with Anacor in District Court of Delaware and launch of the product will depend on litigation outcome.
Alembic has a cumulative total of 128 ANDA approvals (112 final approvals and 16 tentative approvals) from USFDA.