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Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.
FDA announced approval of Opill (norgestrel) tablet for nonprescription use to prevent pregnancy on July 13, 2023. This approval marks the first time a daily oral contraceptive will be available without a prescription, according to an agency press releaes. The approval was granted to Laboratoire HRA Pharma, a pharmaceutical company specializing in products for women in the fields of reproductive health and endocrinology.
According to the press release, norgestrel was granted its original approval for prescription use in 1973. For approval of a product for use in a nonprescription setting, FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively without any assistance from a healthcare professional. FDA based the current approval on studies that demonstrated that consumers had a high overall understanding and a high proportion of individuals who understood the label instructions.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said PatriziaCavazzoni, director, Center for Drug Evaluation and Research, FDA, in the release. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”