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FDA Approves First Over-the-Counter Daily Oral Contraceptive Pill


The US FDA approved norgestrel as the first daily oral contraceptive to be available over the counter, without a prescription.



The US Food and Drug Administration (FDA) today approved norgestrel (Opill, HRA Pharma), a progestin-only pill as the first nonprescription daily oral contraceptive to prevent pregnancy.

The approval of norgestrel tablets provides an option for women to purchase an oral contraceptive pill without a prescription at drug stores, convenience stores, grocery stores and online, according to an FDA press release. Norgestrel should be taken at the same time daily for best effectiveness for preventing pregnancy.

“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, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

Norgestrel was originally approved for prescription use in 1973. HRA Pharma applied to the FDA to switch from prescription to over-the-counter (OTC) approval, according to the agency’s release. Studies of norgestrel as an OTC pill showed that consumer understanding of its drug facts label was high and that most consumers understood the label’s instructions, supporting the ability of consumers to properly use norgestrel when it becomes available as an OTC product, noted the FDA in the release.

The timeline for norgestrel availability and price will be determined by the manufacturer while other approved prescription formulations and doses of other oral contraceptive pills will remain available, according to the release.

The most common side effects of norgestrel include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating, according to the FDA.

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