The pill, a 0.075 milligram norgestrel tablet, “is proposed for nonprescription use as a once daily oral contraceptive to prevent pregnancy,” according to a document published March 29 on the Federal Register.
French drugmaker Laboratoire HRA Pharma filed an application seeking OTC status for its birth control pill, Opill, in July. A few months after the submission, the FDA postponed the original date for the advisory meeting “to review additional information requested related to the Opill Rx-to-OTC switch,” HRA’s parent company, Perrigo, said.
After the delay, 21 attorneys general urged the regulatory agency to approve the drug as they cited the overturn of Roe v. Wade and its subsequent effect on access to reproductive healthcare.
“Women’s needs are nuanced, and it’s about time their health options reflect that,” Frederique Welgryn, global vice president for women’s health at Perrigo, said in a statement. “We’re not only committed to prioritizing women’s health – we’re committed to being active champions for it. We’re reimagining a new world where people are empowered to determine their own sexual health journey and access the solutions they want.”
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