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Biotech / Medical : Sepracor-Looks very promising
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To: j_fir2 who wrote (3163)6/2/1999 4:04:00 PM
From: Don Miller  Read Replies (2) of 10280
 
Reuters read of FDA letter:

*FDA LETTER SAYS SEPRACOR [SEPR-news] MAKES
"UNSUBSTANTIATED" CLAIMS
FOR XOPENEX

NEW YORK, June 2 (Reuters) - The U.S. Food and Drug
Administration has issued a warning letter to Sepracor Inc.
[SEPR-news] asserting the company had made "unsubstantiated
and misleading" safety and efficacy claims about its recently
approved asthma drug, Xopenex.

In a letter dated May 21 obtained by Reuters, the FDA said the
"violative" claims appear in promotional Sepracor materials and "are
inconsistent with the approved product labeling of the drug." The
agency ordered the Massachusetts biotech company to immediately
cease distribution of the materials.

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