The U.S. Food and Drug Administration has approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.
Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.
Opill starts working 2 days after you start taking it, but you must take it every day at the same time each day for it to continue to be effective. You must take Opill continuously every day without a break between blister packs.
Opill was FDA-approved for OTC (over-the-counter) use on July 13, 2023, and should be available in stores starting in January or February 2024.
