Perrigo seeks FDA approval for first OTC birth control pill

July 11, 2022

HRA Pharma, a Perrigo Company, has asked the U.S. FDA to approve a daily birth control pill for over-the-counter sale — the first U.S. request for a contraceptive pill

The announcement comes shortly after the U.S. Supreme Court's decision to overturn the 1973 Roe v. Wade case, but HRA told Reuters it had been in the works for years. "The timing is a bit coincidental. We have been working on that application for the last seven years," said Frédérique Welgryn, HRA Pharma's chief strategic operations and innovation officer.

The HRA drug in question, currently branded under the name Opill, was approved by the FDA back in 1973. First marketed by Pfizer, HRA Pharma acquired it in 2014. It hasn't been sold in the U.S. for over a decade.

OTC health and wellness solutions provider Perrigo recently acquired Opill in its $1.9 billion purchase of France-based  2022  Héra SAS (HRA), which was completed in late April.

HRA expects the FDA to hold an advisory committee meeting and approve the application in the first half of 2023.