The Food and Drug Administration approved a daily oral contraceptive pill for use without a prescription on Thursday, a landmark event that comes as some U.S. states have sought to restrict access to birth control and abortion.
The move clears the way for Opill (norgestrel), which comes in tablet form, to be sold over the counter in a wide range of venues, from online markets to drug stores, convenience stores and grocery stores.
"Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
When used as directed, she added, daily oral contraception such as Opill "is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."
Opill is made by Perrigo, which has its headquarters in Dublin. Opill is deemed a "progestin-only" pill, made with "a synthetic version of the hormone progesterone to prevent pregnancy," as NPR has reported, noting that most birth control pills also contain estrogen.
"Today marks a truly momentous day for women's health nationwide," said Perrigo President and CEO Patrick Lockwood-Taylor, adding that his company's product "has the potential to radically transform women's access to contraception."
As for when the pills — sold in boxes containing a 28-day supply — will hit the market, the FDA says the timeline is up to Perrigo. The company says the pills will be available in stores and online early in the first quarter of 2024. Pricing hasn't been released.
"Other approved formulations and dosages of other oral contraceptives will remain available by prescription only," the FDA said.
