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# Priority NDA for Mycovia’s Yeast Infection Drug
- URL: https://www.fdaweb.com/priority-nda-for-mycovias-yeast-infection-drug/
- Published: 2021-07-28T12:00:00.000Z
- Updated: 2026-09-14T17:08:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149808

FDA has accepted for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating recurrent vulvovaginal candidiasis (chronic yeast infection). The agency has set a 1/27/2022 user fee review action date.

The submission is based on data from three Phase 3 trials involving more than 870 patients. The studies met their primary and key secondary endpoints, demonstrating oteseconazole’s effectiveness in treating recurrent vulvovaginal candidiasis, according to the company. “Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year,” it says.