Lupin gets USFDA nod for generic equivalent of Kerydin Topical Solution
Mumbai, Baltimore: Global pharma major, Lupin Limited, has recently announced that the company has received approval for its Tavaborole Topical Solution, 5%, from the United States Food and Drug Administration (USFDA).
The product is 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).
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.