Lupin gets approval for Tavaborole Topical Solution from USFDA

09 Feb 2021 Evaluate

Lupin has received approval for its Tavaborole Topical Solution, 5%, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Kerydin Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. The product will be manufactured at Lupin's facility in Pithampur, India.

Tavaborole Topical Solution, 5%, is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole Topical Solution (RLD: Kerydin) had estimated annual sales of $76 million in the U.S.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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