Opill FDA Approval History
Last updated by Judith Stewart, BPharm on July 13, 2023.
FDA Approved: Yes (First approved July 13, 2023)
Brand name: Opill
Generic name: norgestrel
Dosage form: Tablets
Company: Perrigo Company
Treatment for: Birth Control
Opill (norgestrel) is a progestin-only, over-the-counter birth control pill for the prevention of pregnancy.
- Opill is a progestin-only birth control pill (also referred to as a mini pill or non-estrogen pill) containing norgestrel 0.075 mg. Norgestrel was first approved as a prescription drug by the U.S. Food and Drug Administration (FDA) in 1973 under the brand name Ovrette. Ovrette was discontinued from U.S. distribution in 2005, with the FDA determining the withdrawal from the market was not for reasons of safety or effectiveness. A supplemental new drug application for a name change to Opill was approved by the FDA in 2017.
- The FDA approved Opill for over-the-counter (OTC) use on July 13, 2023. The use of Opill is not restricted by age, and can be used by any person who has started menstruating. As Opill does not contain estrogen, it can be used in individuals who are unable to take estrogen-based contraceptives. Opill is suitable for use in most individuals who can become pregnant, including those with high blood pressure and those who experience migraines. It is also suitable for use in those who are breastfeeding, those who are perimenopausal, and people who smoke. Opill should not be taken by those who currently have, or who have previously had breast cancer.
- Removing the prescription requirement for Opill improves access to a contraceptive method that is proven to be well tolerated and notably more effective at preventing pregnancy than all current methods of birth control available OTC. It also provides access for those without health insurance or frequent access to medical services.
- Opill works to prevent pregnancy by thickening the cervical mucus, which helps block sperm from reaching the egg. It may also prevent the ovaries from releasing eggs.
- Opill is taken once daily at the same time each day, every day, even during periods of bleeding or spotting.
- Opill is 98% effective at preventing pregnancy when taken at the same time every day. It starts working within 48 hours after taking first pill, so a barrier method such as condoms should be used for the first two days. If a pill is missed by more than 3 hours, the effectiveness of Opill is reduced and a barrier method of contraception should be used for 48 hours until the pill starts working again.
- Opill will be available in store and online at leading retailers across the U.S. early in the first quarter of 2024.
Development timeline for Opill
Further information
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