Perrigo announced U.S. FDA approval for Opill OTC daily oral contraceptive

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On Jul. 13, 2023, Perrigo announced that the U.S. Food and Drug Administration had approved Opill, a progestin-only daily oral contraceptive, for over-the-counter use for all ages. Opill was the first ever birth control pill available over the counter in the United States.

Nearly 50 years of use and scientific evidence demonstrate that progestin-only pills such as Opill® are effective at preventing pregnancy and are safe for most women to use. OTC oral contraception has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Adolescent Health and Medicine and the American Academy of Family Physicians.

Of the 6 million pregnancies in the U.S. each year, 45% are unintended. Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for a contraceptive pill, patch or ring reported difficulties doing so. Removing the prescription requirement for Opill® improves access to a contraceptive method that is effective and well tolerated for all ages of women and people who can get pregnant.

In May 2023, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill® available for OTC use, outweigh the risks.

Opill®, which consists of 0.075 mg norgestrel, will be available in store and online at leading retailers across the U.S. early in the first quarter of 2024.

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Source: Perrigo
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