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U.S. Centers for Disease Control and Prevention • U.S. News
FDA Issues Warning Letter Over Roche Holding AG Fuzeon Comment

July 19, 2005

In a July 15 warning letter posted yesterday to the Food and Drug Administration Web site, the agency said a salesperson for a U.S. unit of Swiss pharmaceuticals firm Roche Holding AG made misleading comments about the firm's HIV drug, Fuzeon, stating it had "100 percent antiviral activity." FDA said clinical studies showed 46 percent of patients had some type of response to the drug. Fuzeon is an injectable drug intended for use in combination with other HIV medications. FDA said Roche must immediately stop disseminating or using materials similar to ones that might have been used by the salesperson, who made the claim last fall at a medical conference in Washington, D.C. A spokesperson for Roche Pharmaceuticals said the company took the matter "very seriously" and would respond to the FDA.

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Excerpted from:
Wall Street Journal
07.19.05


This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.


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