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Lupin gets US FDA nod for Tavaborole Topical Solution

expresspharmaFebruary 10, 2021

Tag: lupin , FDA , Tavaborole , Kerydin , Anacor

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).

Previous:NeuroRx reports Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ (aviptadil) in Reducing Hospital Stay among Patients with Respiratory Failure due to Critical COVID-19

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