Perrigo's HRA Pharma Submits FDA Application for First OTC Birth Control Pill

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Consumer self-care products firm Perrigo Company (NYSE:PRGO) announced Monday that its subsidiary, HRA Pharma, has submitted an application to the United States Food and Drug Administration (FDA) for the first-ever over-the-counter birth control pill in the United States.

Perrigo completed the acquisition of HRA in May this year for €1.8 billion, or approximately $1.9 billion. The company said HRA has applied for an Rx-to-OTC switch for its birth control product, Opill.

If approved, it would be the first daily birth control pill available over-the-counter without a prescription in the US.

“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” said Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

According to Perrigo, various medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, support moving birth control pills OTC.

The company’s shares jumped to year-to-date highs at the start of Monday’s session before giving up most of its gains in the early part of the session, currently trading 1.7% higher.