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Tuesday, April 08, 2008

FDA's Avandia warning hits GSK

Source: The Guardian Blog

April 8, 2008 3:15 PM

GlaxoSmithKline is weaker this afternoon after news that the US regulator, the FDA, had sent a warning letter to the company over its Avandia diabetes drug.

The FDA says Glaxo failed to report some studies on Avandia, and has requested corrections to what it called serious violations. Glaxo said the absence of data was inadvertent*. Sales of the drug plunged when a study last May linked it to an increase in heart attacks. Glaxo is 37p lower at £11.03.

*in·ad·vert·ent

1.unintentional: an inadvertent insult.
2.not attentive; heedless.
3.of, pertaining to, or characterized by lack of attention.

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