AstraZeneca files lawsuit against the FDA for decision regarding quetiapine product labelling and exclusivity

AstraZeneca has filed a lawsuit against the US Food and Drug Administration (FDA) in the US District Court for the District of Columbia to overturn the FDA’s denial on 7 March 2012 of Citizen Petitions filed by AstraZeneca with regard to SEROQUEL® (quetiapine fumarate) tablets and SEROQUEL XR® (quetiapine fumarate) extended release tablets.

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