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Article: DuPont Merck Files Petition Requesting FDA Adopt Different Testing Standards for Warfarin
- Article from:
- PR Newswire
- Article date:
- September 19, 1996
CopyrightCOPYRIGHT 1996 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WILMINGTON, Del., Sept. 19 /PRNewswire/ -- The DuPont Merck Pharmaceutical Company announced today that it has filed a petition with the U.S. Food and Drug Administration asking the Agency to adopt an individual bioequivalence test for warfarin products that the Company believes would help assure that all other warfarin products approved by FDA would have a low level of variability. The anticoagulant medication warfarin is classified by FDA as a narrow therapeutic index (NTI) drug. NTI drugs are a special class of medications for which even slight decreases can result in ineffective therapy, while slight increases may result in toxic effects. The petition also asks FDA to ...