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Solosec FDA Approval History

Last updated by Judith Stewart, BPharm on July 6, 2021.

FDA Approved: Yes (First approved September 15, 2017)
Brand name: Solosec
Generic name: secnidazole
Dosage form: Oral Granules
Company: Lupin Pharmaceuticals, Inc.
Treatment for: Bacterial Vaginosis, Trichomoniasis

Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV) and trichomoniasis.

Development Timeline for Solosec

DateArticle
Jul  1, 2021Approval  Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis
Sep 18, 2017Approval  FDA Approves Symbiomix Therapeutics’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
Mar 23, 2017Symbiomix Therapeutics Announces FDA’s Acceptance of New Drug Application for Solosec with Priority Review Status
Jan 19, 2017Symbiomix Therapeutics Submits New Drug Application to US FDA for Solosec for the Treatment of BV

Further information

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