FDA Sets New Adcomm Date To Review Perrigo's Oral Contraceptive Pill For OTC Use

  • The 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 Perrigo Company plc's PRGO 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 called 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.
  • Perrigo had previously expected approval in the first half of 2023, but the original FDA action date was never disclosed.
  • Price Action: PRGO shares are up 1.29% at $34.63 on the last check Tuesday.
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