AstraZeneca citizen petitions on Quetiapine labeling receives FDA response

AstraZeneca announced that on March 7, the 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, or quetiapine fumarate, tablets and SEROQUEL XR extended-release tablets. AstraZeneca is evaluating the FDA’s decision and reasoning.