FDA Approves First Over-the-Counter Birth Control Pill in the U.S.
On July 13, HRA Pharma's Opill became the first oral contraceptive to be approved by the U.S. Food and Drug Administration (FDA) for over-the-counter sales. The once-daily "mini-pill," which contains only the hormone progestin, first received FDA approval in 1973. Over-the-counter sales of Opill, which HRA Pharma expects to begin early next year, are approved for all users of reproductive age. According to Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, "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." Studies showed that Opill is 93% effective in pregnancy prevention, on par with prescription oral contraceptives. Opill's cost has yet to be announced, but experts note that insurance generally does not cover over-the-counter medications.
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