Drugmaker HRA Pharma is seeking approval from the U.S. Food and Drug Administration (FDA) to sell an over-the-counter birth control pill in the U.S.
HRA Pharma, which is owned by Perrigo Co., submitted an application Monday to sell Opill, a prescription progestin-only daily birth control pill, as an over-the-counter medication. The company acquired the decades-old drug from Pfizer in 2014, but it is not currently marketed in the U.S.
If the company gets approval from the FDA, which could come by next year, it would mark the first over-the-counter daily birth control pill available without a prescription in the U.S., according to Perrigo.
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Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s. They have always required a prescription, generally so health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.