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US Court Denies Preliminary Injunction Application against the FDA and Dismisses AstraZeneca's Lawsuit without Prejudice


AstraZeneca (NYSE: AZN) today announced that on March 23, 2012 the US District Court for the District of Columbia issued an opinion and order in AstraZeneca's lawsuit against the US Food and Drug Administration (FDA) regarding final marketing approval of generic quetiapine. The Court denied the Company's request for a preliminary injunction and dismissed the lawsuit without prejudice.

Notwithstanding the Court's decision, the Company continues to believe strongly in the merits of its position and is evaluating its options. About the lawsuit and the Citizen Petitions

On March 12, 2012, AstraZeneca filed a lawsuit against the FDA to overturn the FDA's denial on March 7, 2012 of the Company's Citizen Petitions with regard to SEROQUEL(R) (quetiapine fumarate) tablets and SEROQUEL XR(R) (quetiapine fumarate) extended release tablets.

In its lawsuit AstraZeneca sought an injunction barring the FDA from granting final marketing approval of generic quetiapine until December 2, 2012 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court had a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.

Posted-In: News FDA Legal


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