Aleor Dermaceuticals receives USFDA Tentative Approval for Tavaborole Topical Solution, 5%

Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) 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, 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.

Tavaborole Topical Solution, 5% has an estimated market size of US$ 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.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.1076.2 as compared to the previous close of Rs. 1080.05. The total number of shares traded during the day was 14637 in over 1356 trades.

The stock hit an intraday high of Rs. 1088.45 and intraday low of 1055.65. The net turnover during the day was Rs. 15701237.

Source : Equity Bulls

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