Current Edition

FDA pushes decision date for Perrigo OTC oral contraceptive

Perrigo, a consumer self-care product company, announced this week that the FDA is postponing the joint AdComm meeting, as well as delaying the drug’s PDUFA date.

The joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee was originally scheduled for November 18 but has been moved to a date that has not yet been determined. According to the FDA, more time is needed to review additional information related to the Opill once-daily oral contraceptive for over-the-counter use application. The drug’s PDUFA date has been pushed back 90 days.

Opill, which can be used both for contraception and pregnancy prevention, would be the first of its kind available without a prescription if the agency okays it. Perrigo’s HRA Pharma applied for an Rx-to-OTC switch for Opill back in July.

Following the Supreme Court’s recent decision to overturn Roe vs. Wade, other companies like Bayer have started lobbying for contraceptive access.