- The FDA has pushed back a decision date on a proposed over-the-counter pill, Opill, from Perrigo Company plc's PRGO subsidiary, HRA Pharma.
- Perrigo had previously expected approval in the first half of 2023, but the exact original FDA action date was never disclosed.
- Perrigo's HRA Pharma applied for the Rx-to-OTC switch on July 11, and such reviews typically take ten months.
- In addition to its decision delay, the FDA also postponed the planned joint meeting by its Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee to discuss Perrigo's application. The conference was previously scheduled for November 18. No new date has been set, Perrigo said.
- The delay comes as the FDA needs more time to review additional information requested from Perrigo related to the application.
- Perrigo will "continue to work collaboratively with the FDA to ensure a timely and thorough review," the company said.
- Price Action: PRGO shares are down 0.92% at $40.93 on the last check Wednesday.
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