FDA Approves Opill (norgestrel) OTC Day by day Oral Contraceptive


DUBLIN, July 13, 2023 /PRNewswire/ — Perrigo Firm plc (NYSE: PRGO), a number one supplier of Client Self-Care Merchandise, introduced in the present day that the U.S. Meals and Drug Administration (FDA) accredited Opill®, a progestin-only day by day oral contraceptive, for over-the-counter (OTC) use for all ages. Opill® is the primary ever contraception capsule obtainable over-the-counter in the US.

“Right now marks a very momentous day for girls’s well being nationwide,” mentioned Perrigo President and Chief Govt Officer Patrick Lockwood-Taylor. “Opill® has the potential to radically remodel girls’s entry to contraception and is a real testomony of Perrigo’s unwavering dedication to ship impactful options that actually make lives higher.”

Practically 50 years of use and scientific proof reveal that progestin-only tablets corresponding to Opill® are efficient at stopping being pregnant and are protected for most girls to make use of. OTC oral contraception has help from main medical organizations together with the American Faculty of Obstetricians and Gynecologists, the American Medical Affiliation, the Society for Adolescent Well being and Drugs and the American Academy of Household Physicians.

“Right now’s approval is a groundbreaking growth for girls’s well being within the U.S., and a major milestone in the direction of addressing a key unmet want for contraceptive entry,” mentioned Frederique Welgryn, Perrigo International Vice President for Girls’s Well being. “Perrigo is dedicated to creating Opill®, which is now the simplest technique obtainable OTC at stopping being pregnant(1), accessible and inexpensive to girls and other people of all ages. I wish to thank the FDA and its advisory panels, the Free The Capsule coalition, the quite a few medical organizations and advocacy teams, and all those that wholeheartedly supported this huge endeavor that has made in the present day a large leap for girls’s empowerment.”

Of the 6 million pregnancies within the U.S. annually, 45% are unintended. Practically one-third of grownup U.S. girls who’ve ever tried to acquire a prescription or refill for a contraceptive capsule, patch or ring reported difficulties doing so. Eradicating the prescription requirement for Opill® improves entry to a contraceptive technique that’s efficient and nicely tolerated for all ages of girls and individuals who can get pregnant.

In Could 2023, the FDA’s Nonprescription Medication Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Medication Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the advantages of creating Opill® obtainable for OTC use, outweigh the dangers.

Opill®, which consists of 0.075 mg norgestrel, can be obtainable in retailer and on-line at main retailers throughout the U.S. early within the first quarter of 2024. For extra data, please go to www.opill.com.

(1) Trussell et al, Contraceptive Know-how. twenty first ed. 2018.

About Perrigo

Perrigo Firm plc (NYSE: PRGO) is a number one supplier of Client Self-Care Merchandise and over-the-counter (OTC) well being and wellness options that improve particular person well-being by empowering customers to proactively stop or deal with circumstances that may be self-managed. Go to Perrigo on-line at www.perrigo.com.

Ahead-Trying Statements

Sure statements on this press launch relate to future occasions and will due to this fact be thought of “forward-looking statements”. Ahead-looking statements contain identified and unknown dangers, uncertainties and different elements, which can trigger the precise outcomes, ranges of exercise, efficiency or achievements of the Firm or its business to be materially totally different from these expressed or implied by such statements. Usually such elements could also be past the Firm’s management, together with the supply of uncooked supplies, labor or manufacturing points, provide chain challenges, actions or omissions by distributors and retailers, market acceptance of latest merchandise, regulatory or legislative motion, third occasion litigation, and different unexpected points. The foregoing and different vital elements, together with these mentioned underneath “Threat Elements” within the Firm’s Type 10-Okay for the 12 months ended December 31, 2022, in addition to the Firm’s subsequent filings with the US Securities and Alternate Fee, may doubtlessly affect the timing and availability of Opill® at retailers in the US, and will trigger precise outcomes, efficiency or achievements to vary materially from these expressed or implied by these forward-looking statements. The forward-looking statements on this press launch are made solely as of the date hereof, and except in any other case required by relevant securities legal guidelines, the Firm disclaims any intention or obligation to replace or revise any forward-looking statements, whether or not because of new data, future occasions, or in any other case.

SOURCE Perrigo Firm plc

Opill (norgestrel) FDA Approval Historical past

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