FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling

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Posted: 9 March 2012 | | No comments yet

The FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling…

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.

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AstraZeneca, Food and Drug Administration (FDA)

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FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling

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