If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
The FDA has postponed the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and the Urologic Drugs Advisory Committee to discuss Perrigo’s application for the nonprescription oral contraceptive. The meeting was originally scheduled for Nov. 18, 2022, to discuss the Opill Rx-to-OTC switch. The date of the new meeting has not yet been determined.
The FDA has postponed the meeting in order to review additional information the agency requested. The agency has also extended the Prescription Drug User Fee Act (PDUFA) date for Opill by 90 days.
Opill is a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill. While progestin-only birth control pills can still increase your risk of blood clots and stroke, they’re generally seen as safer for some women, including those who smoke, have high blood pressure or those at risk for blood clots.
HRA Pharma, a Perrigo company, had submitted its application in July 2022.