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.