Lupin receives USFDA approval for Tavaborole Topical Solution

Lupin announced that it has received approval for its Tavaborole Topical Solution, 5%, from the United States Food and Drug Administration, 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 USD 76 million in the U.S. (IQVIA MAT December 2020).

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