FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling

FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling

Friday, 9 March 2012

AstraZeneca today announced that on 7 March 2012, the FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling that omits certain hyperglycaemia warning language that the FDA required AstraZeneca to include in the labelling for SEROQUEL® (quetiapine fumarate) and SEROQUEL XR® (quetiapine fumarate).

AstraZeneca is evaluating the FDA's decision and reasoning.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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