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News From the Food and Drug Administration
November 4, 1998

Emergency Contraception Kit Approved

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JAMA. 1998;280(17):1472. doi:10.1001/jama.280.17.1472

The FDA has approved an emergency contraception kit (Preven, Gynetics Inc, Somerville, NJ) that is indicated for the prevention of pregnancy in women after known or suspected contraceptive failure or unprotected intercourse. The kit is available by prescription. It consists of a patient information book, a urine pregnancy test, and four emergency contraceptive pills (ECPs), each containing the combination levonorgestrel (0.25 mg) and ethinyl estradiol (0.05 mg).

The professional labeling, patient information, and other material regarding Preven are available at FDA's new drug approval package site on the Internet: http://www.fda.gov/cder/approval/index.htm.