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Article: Glaxo withdraws Lotronex under pressure.(FDA pressures Glaxo Wellcome to withdraw irritable bowel syndrome medication)(Brief Article)
- Article from:
- Medical Marketing & Media
- Article date:
- January 1, 2001
- Author:
CopyrightCOPYRIGHT 2001 Haymarket Media, Inc. 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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On the brink of a decision to take its controversial irritable bowel syndrome drug Lotronex direct-to-consumer as part of a unique risk-management plan, Glaxo Wellcome in December withdrew the product from the marker under FDA pressure. After a tense, two-hour meeting with the agency in Washington on November 28, Glaxo issued a statement saying: "While the company disagrees with the FDAs assessment of the safety profile of the product, Glaxo Wellcome will cease distribution of Lotronex immediately." In a talk paper, the FDA said it presented Glaxo with new risk management options for Lotronex "that included restricting distribution of the drug or marketing withdrawal." It ...