HRA Pharma Files FDA Application for First Over-the-Counter Oral Contraceptive

HRA Pharma has submitted its application for the US’s first over-the-counter (OTC) birth control pill. The company, a subsidiary of Perrigo, filed for a prescription-to-OTC switch for Opill®, a move that would expand access to safe, effective birth control, an imperative as reproductive rights are being revoked in several states.

According to Perrigo, “Opill® consists of 0.075 mg norgestrel and has been used to prevent pregnancy in millions of women in the U.S. since it was FDA 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 2,3 for most women to use. As a daily regular contraceptive, Opill® is to be used pre-conception to be effective at preventing pregnancy.”

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(Source: PR Newswire, July 11th, 2022)