PRGO - Perrigo unit to face FDA AdCom meeting in May for OTC birth control pill

2023-03-28 09:16:22 ET

• The FDA announced Tuesday that a joint advisory committee meeting would be held in May to discuss the marketing application submitted by Perrigo ( NYSE: PRGO ) unit HRA Pharma for oral contraceptive Opill for Over-The-Counter (OTC) use.
• The agency's Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee will virtually meet on May 09 and May 10 to discuss the marketing application.
• Opill, a progestin-only daily birth control pill, is currently available in the U.S. for use with a prescription.
• The FDA's advisory committees issue non- binding recommendations . However, the regulator usually follows them before making a final decision on authorizations.
• Perrigo ( PRGO ) shares fell in October after the FDA postponed the meeting and extended the Prescription Drug User Fee Act (PDUFA) date for its decision by 90 days.

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