Ethinyl Estradiol/Norgestrel

The U.S. FDA has Perrigo's Opill, a progestin-only daily oral contraceptive, for over-the-counter use for all ages — marking the first ever OTC birth control pill available in the U.S. "Today marks a truly momentous day for women's health nationwide," saidPatrick Lockwood-Taylor,Perrigo president and CEO. Although long-anticipated, the agency's decision was not a surprise. Back in , the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) voted 17 to 0, with no abstentions, that the benefits of making Opill available for OTC use outweighed the risks. was first approved by the FDA in 1973 andmarketed by Pfizer as the Rx product Ovrette, until it was discontinued for business reasons in 2005. French drugmakerHRA acquired the rights to Opill in 2015 with the intent to generate the data necessary to support a full Rx-to-OTC switch application, and Perrigo grabbed the reigns when itbought HRA Pharma last Perrigo's HRA Pharma applied for an Rx-to-OTC switch for Opill back in of last year. Then, in , a month before a plannedFDA advisory committee meeting, the agencypostponed the meeting, as well as delayed the drug's PDUFA date for90 days. Now, according to Perrigo, Opill will be available in stores and online in the first quarter of next year. The company will share information on pricing and distribution plans in advance. Assuring access to s has been top of mind for drugmakers since the Supreme Court overturned Roe v. Wade last June. While most of the controversy has been focused on the abortion drug, mifepristone, there is still a lingering concern that states could plunge further into the reproductive health space and seek out ways to restrict access to birth control. Perrigo was one of two drugmakers pursuing anRx-to-OTC switch for a birth control pill. In 2018, bought the rights to two estrogen-progesterone combo oral contraceptives, Lo/Ovral and Alesse, from Pfizer.The company is currently focused on consumer label pivotal studies for its OTC pill, branded as Zena.

An FDA advisory panel voted unanimously in favor of allowing sales of Perrigo's oral contraceptive without a prescription, paving the way for the first OTC birth control pill in the U.S. The Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) voted 17 to 0, with no abstentions, that the benefits of making Opill, a progestin-only daily oral contraceptive, available for over-the-counter (OTC) use outweighs the risks. Perrigo President and CEO Murray Kessler called the vote "a new, groundbreaking chapter in reproductive health." was first approved by the FDA in 1973 andmarketed by Pfizer as the Rx product Ovrette, until it was discontinued for business reasons in 2005. French drugmakerHRA acquired the rights to Opill in 2015 with the intent to generate the data necessary to support a full Rx-to-OTC switch application and Perrigo grabbed the reigns when itbought HRA Pharma last Perrigo's HRA Pharma applied for an Rx-to-OTC switch for Opill back in of last year. Then, in , a month before a plannedFDA advisory committee meeting, the agencypostponed the meeting, as well as delayed the drug's PDUFA date for90 days. Perrigo is one of two drugmakers pursuing anRx-to-OTC switch for a birth control pill. In 2018, bought the rights to two estrogen-progesterone combo oral contraceptives, Lo/Ovral and Alesse, from Pfizer. The company is currently focused on consumer label pivotal studies for its OTC pill, branded as Zena.