FDA: We weren't told about nine studies on Avandia diabetes pills
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GlaxoSmithKline Plc, Europe's largest drugmaker, failed to properly disclose studies of Avandia, the diabetes pills linked to potentially deadly side effects, U.S. regulators said, according to an article on April 8, 2008 from Bloomberg.
The Food and Drug Administration posted a letter on its Website, saying that the drug giant's violations "are serious and may be symptomatic of underlying post-marketing safety reporting failures."
According to the Bloomberg report, the FDA said it was never told about nine studies and an additional 11 weren't included in required annual reports from 2001 to 2007.
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see also:
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Sales Plunge
Report: Avandia's Sales Plunge After Study Raises Safety ConcernsStudy Suggested Avandia Had Safety Concerns, Raised Heart Attack Risk
News & Warnings
Avandia Breaking News: Glaxo Warned in 2001 about Misleading MarketingBloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001


