Lupin gets USFDA nod for generic antifungal solution

The drug major 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 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).

On a consolidated basis, Lupin reported net profit of Rs 441.35 crore in Q3 FY21 as against a net loss of Rs 840.36 crore reported in Q3 FY20. Net sales increased 5.4% to Rs 3,917.30 crore in Q3 FY21 from Rs 3,716.09 crore in Q3 FY20.

Shares of Lupin fell 0.96% at Rs 1,059.35. Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets.

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