26.10.2022 15:14:58
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Perrigo: FDA Postpones Meeting To Review Additional Information Requested Related To Opill
(RTTNews) - Perrigo Company plc (PRGO) has received notification that the FDA has postponed the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, previously planned for November 18, 2022, to discuss the application for Opill once daily oral contraceptive for OTC use. FDA postponed the meeting in order to review additional information requested. The PDUFA date for Opill has been extended by 90 days.
Perrigo Company said it will continue to work collaboratively with the FDA to ensure a timely and thorough review.
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