Femlyv FDA Approval History
Last updated by Judith Stewart, BPharm on July 29, 2024.
FDA Approved: Yes (First approved July 22, 2024)
Brand name: Femlyv
Generic name: ethinyl estradiol and norethindrone acetate
Dosage form: Orally Disintegrating Tablets
Company: Millicent Puerto Rico LLC
Treatment for: Birth Control
Femlyv (ethinyl estradiol and norethindrone acetate) is an orally disintegrating tablet (ODT) formulation of an approved estrogen and progestin combination indicated for use by females of reproductive potential to prevent pregnancy.
- The ethinyl estradiol and norethindrone acetate combination oral contraceptive was first approved in tablet formulation for the prevention of pregnancy in 1968. Femlyv is the first approved ethinyl estradiol and norethindrone acetate combination in an orally disintegrating tablet formulation.
- Femlyv works to lower the risk of becoming pregnant primarily by suppressing ovulation.
- Femlyv is supplied a carton of three pouches, with each pouch containing a blister card of 28 ODTs. Each blister card contains 24 active ODTs containing norethindrone acetate 1 mg and ethinyl estradiol 0.02 mg, and 4 inert ODTs. Femlyv is taken at the same time once daily without regards to meals. Each ODT is placed on the tongue and allowed to disintegrate before swallowing.
- Femlyv carries a Boxed Warning for an increased risk of serious cardiovascular events in women who smoke cigarettes. Women over 35 years of age who smoke should not take Femlyv.
- Common adverse reactions include headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
Development timeline for Femlyv
| Date | Article |
|---|---|
| Jul 23, 2024 | Approval FDA Approves Femlyv (norethindrone acetate and ethinyl estradiol) Orally Disintegrating Birth Control Pill |
Further information
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