Lupin’s arm gets USFDA’s nod for supplemental new drug application for SOLOSEC

02 Jul 2021 Evaluate

Lupin’s U.S. based wholly-owned subsidiary -- Lupin Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (USFDA) for its 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.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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