FDA AdComm backs Perrigo OTC birth control pill

2023-05-12

上市批准并购

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."

Opill was first approved by the FDA in 1973 and marketed by Pfizer as the Rx product Ovrette, until it was discontinued for business reasons in 2005. French drugmaker HRA 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 it bought HRA Pharma last year.

Perrigo's HRA Pharma applied for an Rx-to-OTC switch for Opill back in July of last year. Then, in October, a month before a planned FDA advisory committee meeting, the agency postponed the meeting, as well as delayed the drug's PDUFA date for 90 days.

Perrigo is one of two drugmakers pursuing an Rx-to-OTC switch for a birth control pill. In 2018, Cadence OTC 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.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构