Perrigo Company plc's PRGO HRA Pharma has submitted its application to the FDA for the first-ever over-the-counter (OTC) birth control pill, the first such request for this type of contraception.
The product has been sold as a prescription drug as Opill since 1973, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).
The application comes on the back of the U.S. Supreme Court's decision in June to overturn the 1973 Roe v. Wade case that made abortion legal nationwide.
Related: This $5B Pharmaceutical Could Benefit From Over-The-Counter Contraceptives And Plan B Alternatives.
Reuters reported that HRA Pharma expects FDA to hold an advisory committee meeting and approve the application in 1H of 2023, which is typical for such requests, said Frédérique Welgryn, HRA Pharma's chief strategic operations, and innovation officer.
"The timing is a bit coincidental. We have been working on that application for the last seven years," Welgryn said.
Major medical organizations have expressed support for moving birth control pills OTC.
Nearly one-third of adult U.S. women who have tried to obtain a prescription or refill for a contraceptive option reported difficulties doing so.
The company said that removing the prescription requirement with Opill would improve access to a well-tolerated and effective contraceptive method.
Price Action: PRGO shares are up 1.78% at $41.83 during the market session on the last check Monday.
Image by Gabriela Sanda from Pixabay
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