Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) for the Treatment of Trichomoniasis
Retrieved on:
Thursday, July 1, 2021
[1] SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women.
Key Points:
- [1] 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.
- Research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV,[2]" said Jon Stelzmiller, President Specialty, Lupin Pharmaceuticals, Inc.
- SOLOSEC(secnidazole) 2 g oral granules is an antimicrobial agent indicatedfor the treatment of BV in adult women and trichomoniasis in adults.