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.
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® (quetiapine fumarate) tablets and SEROQUEL XR® (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.
On September 9, 2011 AstraZeneca filed a Citizen Petition with the FDA for each of SEROQUEL and SEROQUEL XR, requesting the FDA withhold finally approving any generic quetiapine product that omits from its labeling certain warning language that FDA required AstraZeneca to include in the labeling for SEROQUEL and SEROQUEL XR. Data associated with the warning language at issue is protected by marketing exclusivity periods expiring as late as December 2, 2012. In the Citizen Petitions, AstraZeneca raised important issues regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials.
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