Perrigo Company plc
On Thursday, the Food and Drug Administration approved a daily oral contraceptive pill for use without a prescription, a historic event that comes as some US states sought to limit access to birth control and abortion.
The move paves the way for Opill (norgestrel), which comes in tablet form, to be sold in a range of venues, from online marketplaces to drugstores, convenience stores and grocery stores.
« Today’s approval marks the first time that a daily nonprescription oral contraceptive will be an option available to 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 non-prescription methods of contraception at preventing unwanted pregnancy. »
Opill is manufactured by Perrigo, which is based in Dublin. Opill is considered a « progestin-only » pill, made with « a synthetic version of the hormone progesterone to prevent pregnancy, » as NPR reported, noting that most birth control pills also contain estrogen.
« Today marks a really big day for women’s health nationwide, » She said Perrigo president and chief executive officer Patrick Lockwood-Taylor added that his company’s product « has the potential to fundamentally transform women’s access to contraception. »
As for when the pills — sold in boxes containing a 28-day supply — hit the market, the FDA says the timing is up to Perrigo. The company says the pills will be available in stores and online in early Q1 2024. Pricing has not been disclosed.
« Other approved formulations and strengths of other oral contraceptives will remain available by prescription only, » the FDA said.