To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Levlite Low-Dose Oral Contraceptive URL: http://www.pslgroup.com/dg/8E75E.htm Doctor's Guide July 14, 1998
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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.