Perrigo Company plc
Opill is the first-ever birth control pill available over the counter in the U.S.
The company says that nearly 50 years of use and scientific evidence demonstrate that progestin-only pills such as Opill are effective at preventing pregnancy and safe for most women.
In May, the FDA's Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill available for OTC use, outweigh the risks.
In May, the FDA released briefing documents citing concerns that the safety and effectiveness of such pills would be contingent on how consumers can appropriately use them.
Opill carries "important risks," particularly in those with a history or risk of breast cancer or other progestin-sensitive cancers, vaginal bleeding of undiagnosed etiology. Opill can also interact with other medications, the FDA said.
Opill, which consists of 0.075 mg norgestrel, will be available in-store and online at leading retailers across the U.S. early in the first quarter of 2024.
Price Action: PRGO shares are up 2.05% at $33.76 on the last check Thursday.
