Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.
- Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.
- Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year.
- With this timeline and pending full FDA review and approval, Mycovia is preparing for a U.S. launch of oteseconazole in early 2022.
- Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).