HRA Pharma files for first-ever OTC birth control pill in USA

Shares of Dublin, Ireland-incorporated Perrigo Company (NYSE: PRGO) were up 2.2% at $42.00 pre-market today, after it announced that its subsidiary HRA Pharma has submitted its application to the US Food and Drug Administration (FDA) for the first-ever over-the-counter (OTC) birth control pill in the USA.

The company has applied for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill). If approved, this would be the first daily birth control pill available OTC without a prescription in the USA.

"This historic application marks a ground-breaking moment in contraceptive access and reproductive equity in the US," said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, adding: "More than 60 years ago, prescription birth control pills in the US empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."