FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

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AstraZenecaMar 12 2012

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AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration ("FDA") denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca (NYSE: AZN) to include in the labeling for SEROQUEL^® (quetiapine fumarate) tablets and SEROQUEL XR^® (quetiapine fumarate) extended-release tablets. AstraZeneca is evaluating the FDA's decision and reasoning.

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