WASHINGTON, D.C. — The Food and Drug Administration (FDA) this week approved Femlyv, the first orally disintegrating tablet for preventing pregnancy. This new form of birth control offers an alternative for those who struggle with swallowing pills.
Femlyv contains norethindrone acetate and ethinyl estradiol, ingredients that have been used in traditional swallowable tablets for contraception since 1968. The approval marks a significant advancement in expanding access to birth control.
“Femlyv is the first FDA-approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research.
The most common side effects include headaches, yeast infections, nausea, menstrual cramps, and breast tenderness. Other reported reactions are bacterial vaginitis, abnormal cervical smears, acne, mood swings, and weight gain.
The FDA’s decision to approve Femlyv provides a new option for contraception, addressing the needs of individuals who face difficulties with traditional pills. This innovation underscores the FDA’s commitment to broadening healthcare options and improving patient access to essential medications.
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