Tuesday, April 8, 2008

FDA Faults Glaxo For Failure to Report on Avandia Studies

With all the Vytorin news lately, we’d almost forgotten about Avandia, GlaxoSmithKline’s beleaguered diabetes drug. FDA didn’t. An agency inspection of GSK’s North Carolina offices found that the company “failed to report data relating to clinical experience” for the drug, according to this letter the FDA recently sent to GSK. The drug maker failed to [...]

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