NDA 218718, held by Millicent Mfg Pr. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 13, 2026, NDA 218718 (Femlyv), held by Millicent Mfg Pr, was first approved by FDA on Jul 22, 2024, with 1 approved supplement and 0 published complete response letters.
FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Femlyv0.02MG;1MG · tablet, orally disintegrating;oral | Ethinyl Estradiol; Norethindrone Acetate | RxReference drug |
| Jul 29, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Jul 22, 2024 | Original applicationNew dosage form · 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
