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# Opill Approved as 1st OTC Oral Contraceptive
- URL: https://www.fdaweb.com/opill-approved-as-1st-otc-oral-contraceptive/
- Published: 2023-07-13T12:00:00.000Z
- Updated: 2026-09-14T18:44:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154867

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](https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive?ref=fdaweb.com) says. 

Opill was approved after the company [demonstrated](http://email.prnewswire.com/ls/click?upn=OXp-2BEvHp8OzhyU1j9bSWuwMvMWelqIco5RbfBrouY-2BTA-2FXIqZcBFrAINr6WcBftIQpMx-2Fbp-2BROXWyhNsvNkqR0fGaaHE0UsOPVZyVci2tZS9SLIKPbqNHfKZN-2FXkitQVNIHnam-2FWpZalSXs-2BnphM4Ows2r2QvyIuYtF2QVYhyKbJXkGe-2BMm4W7YNKMa1yFWcUpMkJvSyM5wPr2CtBgEAV7MFWuwkMTwNU0-2FE7Nps-2FJsah7FEps8yaaBh4c93TA5BBTqC%5FxCGFIN3nMOPWun4BAdUrZI6NUVIWPuhGNPih1t9UspWUawZ-2BSsLNM-2FdqNsHgZvBOtaNBrRH-2FjERQTnkbfsIBtJK3qXt-2FxYY0lMCoqRO-2BlXZoO6-2F8T1Ax6PYW25CzTJHk2ngkugUjtEa6yh4Y68FH68CCyz-2BHZC-2FnwQgnipCIYr-2BrNBZh5SmJb8zz4eq7A-2B22WqfVP9rbbw2PaJGDBtGwpP0Vzd7vxFl0YyDRGN2poyCqwbt4BQl-2BzntfdkhriFxNY-2BxwBf9sWbQrSd5EZQ5saGZl7Bko8ZfCS-2F-2BK-2FwurB2bbp-2FvnkVej6489uzgkxj0n9YwGVySshFnsNugC2-2FtcIhBwG4qkHfpxHPD7EU9vClYic-2Ft-2Bowguj2dxaETZnrG-2F&ref=fdaweb.com) 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.”