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FDA Approves Levlite Low-Dose Oral Contraceptive WAYNE, NJ -- July 14, 1998 -- The United States Food and Drug Administration has approved Berlex Laboratories, Inc.’s Levlite(TM) (levonorgestrel 0.100 mg and ethinyl estradiol 0.020 mg tablets, USP), a low-dose 20 microgram oral contraceptive (OC). Levlite, which offers patients an effective OC option with the lowest available hormonal dose in a combination OC, will be available to physicians and consumers before the end of the year. In multicentre clinical trials, Levlite was proven to have a safety and efficacy profile like the higher-dose levonorgestrel OCs that have been marketed in the U.S. for more than 20 years. In addition to proven contraceptive efficacy, there is a low potential for hormone-related side effects with this new low-dose product. Levlite will be packaged in a convenient, easy-to-use calendar pack. Serious as well as minor adverse reactions have been reported with the use of all oral contraceptives. Physicians should consult full-prescribing information before prescribing or administering OCs. Estrogens should not be used by patients with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis or thrombo-embolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma. E-mail this page to a friend or colleague! To print, use this version