- The The FDA has postponed the appointment a joint meeting of the Advisory Committee on Non-Prescription Drugs (NDAC) and the Advisory Committee on Obstetrics, Reproductive Medicine and Urological Drugs (ORUDAC) on 9-10 May 2023 for review Perrigo Company plc‘S PRGO Opill daily oral contraceptive available over-the-counter (OTC).
- Perrigo announced in July 2022 that its subsidiary HRA Pharma had submitted an application to the FDA for an Rx-to-OTC switch of Opill, a progestogen-only pill for daily contraception (also known as the minipill or non-estrogen pill) .
- If approved, Opill would be the first birth control pill available over-the-counter and without a prescription in the United States
- Over-the-counter birth control is supported by major medical organizations.
- Perrigo had previously expected approval in the United States first half of 2023but the original FDA action date was never announced.
- Price promotion: PRGO shares are up 1.29% to $34.63 on Tuesday’s latest check.
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