Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (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).
Tavaborole Topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton. rubrum or Trichophyton mentagrophytes. Aleor had previously received tentative approval for this ANDA. Aleor was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity. Tavaborole Topical Solution, 5% has an estimated market size of US$ 82 million for twelve months ending June 2020 according to IQVIA.
Alembic has a cumulative total of 133 ANDA approvals (116 final approvals and 17 tentative approvals) from USFDA