AstraZeneca Seroquel petitions denied by US FDA
The US Food and Drug Administration had denied Citizen Petitions filed by Anglo-Swedish drug major AstraZeneca (LSE: AZN) requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the agency required of the company’s branded product to include in the labeling for its antipsychotic Seroquel (quetiapine fumarate) and Seroquel XR (extended release).
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