Treats bacterial vaginosis in females 12 years of age and older. NDA 205223, held by Alembic Therap. Metronidazole.
As of Nov 15, 2026, NDA 205223 (Nuvessa), held by Alembic Therap, was first approved by FDA on Mar 24, 2014, with 4 approved supplements and 0 published complete response letters.
NUVESSA is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.
| Aug 3, 2018 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Mar 24, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nuvessa1.3% · gel;vaginal | Metronidazole | RxReference drug |
| Feb 25, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Dec 6, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Aug 3, 2018 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 24, 2014 | Original applicationNew formulation or manufacturer · Standard 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
