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Lupin gets US FDA nod for Tavaborole Topical Solution

It is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes

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Lupin has received approval for its Tavaborole Topical Solution, 5%, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Kerydin Topical Solution, 5%, of Anacor Pharmaceuticals. 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 US (IQVIA MAT December 2020).

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