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Tuesday, March 28, 2023

Perrigo: New Date for Joint FDA AdComm to Review Opill® Daily Oral Contraceptive for OTC

 Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that the U.S. Food and Drug Administration (FDA) has rescheduled a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) for May 9 & 10, 2023, to review the Company's application for Opill® daily oral contraceptive for over-the-counter (OTC) use.

Perrigo announced in July 2022 that its HRA Pharma affiliate filed an application with the FDA for the Rx-to-OTC switch of Opill®, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill). If approved, Opill® would be the first ever daily birth control pill available OTC, without a prescription, in the U.S. Over-the-counter birth control has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians.

https://finance.yahoo.com/news/perrigo-announces-date-joint-fda-125800944.html

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