Alembic Pharma JV gets USFDA tentative nod for Tavaborole Topical Solution

Aleor Dermaceuticals Limited, a joint venture of Alembic Pharmaceuticals Limited, has received tentative approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application -Tavaborole Topical Solution.

Aleor is a joint venture of Alembic with Orbicular Pharmaceutical Technologies Pvt Ltd, which focusses on commercialising dermatology products globally. The solution is an antifungal used for the treatment of onychomycosis of the toenails due to Trichophyton mentagrophytes or Trichophyton rubrum. This is therapeutically equivalent to the reference listed drug product (RLD), Kerydin Topical Solution, 5 per cent, of Anacor Pharmaceuticals Inc.

According to IQVIA, Tavaborole Topical Solution 5 per cent has an estimated market size of US$ 82 million for twelve months ending June 2020.

Alembic is currently in litigation with Anacor in the District Court of Delaware and depending upon its outcome, the launch of the product would be made.

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