PRGO - Perrigo to face FDA AdCom meeting for OTC contraceptive

• Ireland-based pharma Perrigo Company plc ( NYSE: PRGO ) announced Monday that the FDA scheduled a meeting of its independent experts on Nov. 18 to decide on its marketing application for oral contraceptive Opill for Over-The-Counter (OTC) use.
• A progestin-only daily birth control pill, Opill was available in the U.S. for those with a prescription since the FDA first approved it in 1973.
• At the November joint meeting, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) will decide its approvability for OTC use.
• A favorable outcome will pave the way for Opill to become “the first ever daily birth control pill available OTC without a prescription in the U.S.,” PRGO said.
• In July, the company announced its affiliate HRA Pharma had submitted an application to the FDA seeking approval for an Rx-to-OTC switch of Opill.

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