Last Updated on December 31, 2023 by The Health Master
Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (FDA) 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.
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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 US FDA.
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