Lupin gets tentative approval for Efinaconazole Topical Solution

Lupin announced that it has received tentative approval for its Efinaconazole Topical Solution, 10%, from the United States Food and Drug Administration, to market a generic equivalent of Jublia Topical Solution, 10%, of Bausch Health Americas, Inc.

Efinaconazole Topical Solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. Efinaconazole Topical Solution, 10%, (RLD: Jublia) had estimated annual sales of $222.9 million in the U.S. (IQVIA MAT September 2020).

The announcement was made after market hours on Thursday, 24 December 2020. Shares of Lupin rose 1.37% to settle at Rs 976.15 on Thursday.

The stock hit a 52-week high of Rs 1121.85 on 18 September 2020. The stock hit a 52-week low of Rs 505 on 13 March 2020.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai. 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions

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