FDA Rebuffs AstraZeneca’s Bid To Delay Generic Seroquel

Law360, New York (March 9, 2012, 7:22 PM EST) -- The U.S. Food and Drug Administration has rejected AstraZeneca PLC’s bid to delay the launch of generic versions of the U.K.-based pharmaceutical giant’s blockbuster anti-psychotic drug Seroquel, the company said Friday.

AstraZeneca said the FDA denied its petition requesting that the agency hold off on granting final approval of any generic with labeling that omits certain warning language concerning hyperglycemia, a symptom of diabetes that the FDA required AstraZeneca to include on its Seroquel labels.

The company said it was evaluating the FDA’s decision and reasoning....
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