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Dec 09, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Avandia rosiglitazone regulatory update

FDA said it will remove prescribing and dispensing restrictions the agency placed on diabetes drug Avandia rosiglitazone from GlaxoSmithKline in 2010. The agency made the decision based on the re-adjudication of the RECORD cardiovascular outcomes trial, which showed no evidence Avandia increased the risk of all-cause mortality or a composite of cardiovascular death, myocardial infarction (MI) or stroke. According to FDA, the re-adjudication provides "adequate assurance" that the cardiovascular...

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