Opill Approved as 1st OTC Oral Contraceptive

FDA has approved a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over-the-counter status. “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,” an agency release says. 

Opill was approved after the company demonstrated that the “product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional,” the agency says. “Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product.”