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FDA Replies To AstraZeneca Citizen Petitions On Quetiapine Product Labeling

AstraZeneca Plc (AZN,AZN.L) announced that on March 7, 2012, the Food and Drug Administration, or 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 to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

The company stated that it is evaluating the FDA's decision and reasoning.

by RTT Staff Writer

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