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# HRA Pharma Files for OTC Birth Control Pill
- URL: https://www.fdaweb.com/hra-pharma-files-for-otc-birth-control-pill/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152242

HRA Pharma, a Perrigo company, has submitted an NDA that, if approved, would be the first over-the-counter (OTC) birth control pill in the U.S. The Rx-to-OTC switch application is for the company’s Opill (norgestrel .075 mg), a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill) that was first approved in 1973.

“Nearly fifty years of use and scientific evidence show that progestin-only pills like Opill are effective at preventing pregnancy and are safe for most women to use,” the company says. “As a daily regular contraceptive, Opill is to be used pre-conception to be effective at preventing pregnancy.”