Lupin gets US FDA nod for Tavaborole Topical Solution

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).