PRGO - Perrigo drops as FDA postpones AdCom meeting on OTC birth control pill

Ireland-based pharma Perrigo ( NYSE: PRGO ) slipped in the morning hours Wednesday after announcing that the FDA has postponed a meeting for its advisory committee that was scheduled to discuss the marketing application for oral contraceptive Opill for Over-The-Counter (OTC) use.

The progestin-only daily birth control pill is currently available in the U.S. for use with a prescription.

Previously, the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee were set to hold a joint meeting on Nov. 18 to discuss the Rx-to-OTC switch of Opill.

However, the regulator has rescheduled the meeting to review additional data, Perrigo ( PRGO ) said, adding that the FDA has also extended the Prescription Drug User Fee Act (PDUFA) date for its decision by 90 days. The new date for the meeting has not been set yet.

In July, the company announced its affiliate HRA Pharma submitted the marketing application for the Rx-to-OTC switch of Opill.

Subsequently, the FDA determined that its decision to allow the launch of the first-ever daily birth control pill without a prescription in the U.S. will require an AdCom meeting.

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