Solosec

NDA 209363, held by Evofem Inc. Secnidazole.

As of Nov 13, 2026, NDA 209363 (Solosec), held by Evofem Inc, was first approved by FDA on Sep 15, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 15, 2017
Review: Priority
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SOLOSEC is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older. Treatment of trichomoniasis in patients 12 years of age and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Bacterial Vaginosis SOLOSEC is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Jan 26, 2022	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 26, 2022	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 30, 2021	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 15, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Solosec2GM/PACKET · granule;oral	Secnidazole	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Jan 26, 2022	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 26, 2022	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 15, 2021	Supplement 17Labeling · Standard review	Approved	Letter Label
Jun 30, 2021	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 14, 2021	Supplement 15Labeling · Standard review	Approved	Letter Label
Sep 15, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 209363
Drugs@FDA: Overview at FDA
Company: Evofem

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters