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Dr Marie Sartain
/ Categories: APhA News

FDA panel considers OTC birth control

FDA advisers are slated to meet in early May to discuss whether the agency should approve an OTC oral contraceptive.

If approved, HRA Pharma’s Opill would be the first-ever daily birth control available OTC in the United States. Opill has been available with a prescription since its approval 50 years ago.

HRA Pharma submitted an application to switch from prescription to OTC status last July, and in October a previously scheduled FDA meeting was pushed back to review additional data requested by the company.

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