Lupin said that its U.S. based wholly-owned subsidiary Lupin Pharmaceuticals, Inc., has received supplemental new drug application approval from US regulator for Solosec.
Lupin said that its U.S. based wholly-owned subsidiary Lupin Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to expand the use of SOLOSEC (secnidazole) to include the treatment of trichomoniasis in adults.
Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated three to five million people every year. SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women.
The supplemental approval makes SOLOSEC the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
The announcement was made after market hours yesterday, 1 July 2021. Shares of Lupin fell 0.26% to settle at Rs 1,146.25 yesterday.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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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