To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Thalidomide Submitted for NDAs for Use In Leprosy and AIDS Cachexia URL: http://www.pslgroup.com/dg/DAA6.htm Doctor's Guide November 11, 1996
WARREN, N.J., Nov. 11, 1996 -- Celgene Corporation (Nasdaq: CELG) today reconfirmed that it will submit a New Drug Application (NDA) by the end of 1996 with the Food and Drug Administration for the use of thalidomide in the treatment of erythema nodosum leprosem (ENL), a disorder associated with leprosy. The company met November 8 with the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA. Following the closed meeting, Celgene Chairman and CEO John W. Jackson said his company will move ahead with submission plans and is hoping for a timely and favorable review. Celgene has completed the pivotal trial for the use of thalidomide in AIDS-related cachexia, a severe weight loss and wasting condition. Assuming satisfactory safety and efficacy data, the company plans to move forward to submit an NDA in this indication also. Celgene Corporation, headquartered in Warren, N.J., uses proprietary expertise in small molecule chemistry to serve the pharmaceutical and allied industries. --------------------------------------------------------------------------------------------- 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.