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Solosec FDA 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 Timeline for Solosec

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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