NDA 209627, held by Mayne Pharma. Ethinyl Estradiol; Segesterone Acetate.
As of Nov 14, 2026, NDA 209627 (Annovera), held by Mayne Pharma, was first approved by FDA on Aug 10, 2018, with 2 approved supplements and 0 published complete response letters.
ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use ANNOVERA has not been adequately studied in females with a BMI >29 kg/m 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2018 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Annovera0.013MG/24HR;0.15MG/24HR · ring;vaginal | Ethinyl Estradiol; Segesterone Acetate | RxReference drug |
| Sep 10, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Aug 10, 2018 | Original applicationNew molecular entity, new combination · 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
