NDA 215888, held by Mycovia Pharms. Oteseconazole.
As of Nov 14, 2026, NDA 215888 (Vivjoa), held by Mycovia Pharms, was first approved by FDA on Apr 26, 2022, with 1 approved supplement and 0 published complete response letters.
VIVJOA is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. 1.1 Vulvovaginal Candidiasis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vivjoa150MG · capsule;oral | Oteseconazole | RxReference drug |
| Apr 11, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Apr 26, 2022 | Original applicationNew molecular entity · Priority review | Approved |
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
