Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive
"Today marks a truly momentous day for women's health nationwide," said Perrigo President and Chief Executive Officer Patrick Lockwood-Taylor. "Opill® has the potential to radically transform women's access to contraception and is a true testament of Perrigo's unwavering commitment to deliver impactful solutions that truly make lives better."
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.
"Today's approval is a groundbreaking expansion for women's health in the
Of the 6 million pregnancies in the
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
(1) Trussell et al, Contraceptive Technology. 21st ed. 2018.
Perrigo Company plc (NYSE: PRGO) is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at www.perrigo.com.
Certain statements in this press release relate to future events and may therefore be considered "forward-looking statements". Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by such statements. Often such factors may be beyond the Company's control, including the availability of raw materials, labor or manufacturing issues, supply chain challenges, actions or omissions by distributors and retailers, market acceptance of new products, regulatory or legislative action, third party litigation, and other unforeseen issues. The foregoing and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2022, as well as the Company's subsequent filings with the United States Securities and Exchange Commission, could potentially impact the timing and availability of Opill® at retailers in
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SOURCE Perrigo Company plc