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Solosec Approval History

FDA Approved: Yes (First approved September 15, 2017)
Brand name: Solosec
Generic name: secnidazole
Dosage form: Oral Granules
Company: Symbiomix Therapeutics, LLC
Treatment for: Bacterial Vaginitis

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

Development History and FDA Approval Process for Solosec

DateArticle
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
May 26, 2016Symbiomix Therapeutics Announces Positive Results from Phase 3 Trial of SYM-1219 for Bacterial Vaginosis
Jun  9, 2015Symbiomix Therapeutics Doses First Patient in Confirmatory Phase 3 Pivotal Study of Lead Drug Candidate SYM-1219 for Bacterial Vaginosis

Further information

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