NDA 214154, held by Mayne Pharma. Drospirenone; Estetrol.
As of Nov 14, 2026, NDA 214154 (Nextstellis), held by Mayne Pharma, was first approved by FDA on Apr 15, 2021, with 1 approved supplement and 0 published complete response letters.
NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2021 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nextstellis3MG;14.2MG · tablet;oral | Drospirenone; Estetrol | RxReference drug |
| Apr 29, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Apr 15, 2021 | 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
