LONDON and PHILADELPHIA, April 8, 2008 /PRNewswire-FirstCall/ --
GlaxoSmithKline (NYSE: GSK) today confirmed it has received a warning
letter from the US Food and Drug Administration (FDA) related to reporting
requirements for approved medicines. The letter follows a routine FDA
inspection of GSK's reporting processes conducted last year.
The observations from the inspection primarily relate to omissions from
periodic reports to the FDA regarding Avandia(R) (rosiglitazone maleate),
such as the start and progress of clinical trials, and summaries of final
data from some clinical trials.
The FDA inspection also reviewed GSK's processes for reporting
individual adverse events, which resulted in no inspection citations. The
inspection found nothing to suggest that procedures for prompt reporting of
adverse events was compromised.
"We take these findings seriously, and corrective steps to make sure we
file periodic reports completely and promptly have been taken or are
underway," said Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline.
"These omissions did not interfere with the timely reporting of adverse
event information to the FDA."
GSK is committed to taking the appropriate steps to address the
concerns raised by the FDA.
After the inspection, GSK initiated a review of applicable processes
and reporting systems. The company has made and will continue progress in
updating its procedures and improving compliance in this area of reporting,
including additional training for employees to ensure that all procedures
are followed across all product lines.
The FDA letter acknowledges that information not captured in the
periodic reports was, in many cases, submitted to the Agency in other
reports and communications. Beyond that, information about the start of
clinical trials omitted from some reports was available through posting on
clinicaltrials.gov. GSK submitted a corrected 2007 Avandia annual report to
the FDA in September 2007, ahead of the FDA's updated final decision on
approved labeling for Avandia in November 2007. Clinical trial results are
also posted publicly to GSK's clinical trial register.
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at http://www.gsk.com.
SOURCE GlaxoSmithKline
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http://clinicaltrials.gov
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or Gary Davies, +(020) 8047 5503, all of GlaxoSmithKline
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