The drugmaker’s unit, HRA Pharma, submitted an application to the health regulator in July to make its prescription contraceptive drug, Opill, an over-the-counter pill.
Since the US Supreme Court’s decision in June to overturn Roe v. Wade in 1973, which legalized abortion nationwide, the spotlight is on access to contraception.
Abortion rights activists have escalated calls for mifepristone, which, when combined with misoprostol, causes abortion up to 10 weeks gestation, to be made available without a prescription.
Opill, a non-estrogen contraceptive, has been used by prescription since its approval in 1973. If the FDA approves HRA Pharma’s application, Opill would become the first over-the-counter daily contraceptive pill in the United States.
HRA said in July that it expected a decision from the FDA in the first half of 2023.