market, explicitly as an over-the-counter drug. HRA Pharma updated the pill's label in 2017 in hopes of reintroducing the medication to the U.S. sales of the pill in 2005 for business reasons, according to the agency. The FDA originally approved norgestrel in 1973 as a prescription drug, but the company stopped U.S. "I urge the FDA to approve over-the-counter availability of Opill," Roth said, in explaining her vote in favor of HRA Pharma's application. Katalin Roth, a member of the FDA advisory panel and a professor of medicine at George Washington University. "The history of women's contraception is a struggle for women's control over their reproduction and we need to trust women," said Dr. If the FDA approves HRA Pharma's application, women could obtain Opill without first having to visit a doctor or other health-care provider. Since they were approved in the United States more than 60 years ago, oral contraceptives have only been available to women with a prescription for their use. The Paris-based drugmaker is owned by Perrigo, a manufacturer of over-the-counter drugs. The FDA is not obligated to follow the recommendations of its independent advisors, all 17 of whom voted "yes" on the proposal after a two-day hearing.īut HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. Personal Loans for 670 Credit Score or Lower Personal Loans for 580 Credit Score or Lower Best Debt Consolidation Loans for Bad Credit
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