Alembic Pharmaceuticals’ joint venture Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tavaborole Topical Solution, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. (Anacor).
Aleor had previously received tentative approval for this ANDA. Tavaborole Topical Solution, 5% has an estimated market size of $82 million for twelve months ending June 2020. Alembic has a cumulative total of 133 ANDA approvals (116 final approvals and 17 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
