AstraZeneca files lawsuit against FDA regarding quetiapine

Wednesday, March 14, 2012 09:56 AM

AstraZeneca has filed a lawsuit against the FDA in district court to overturn the FDA’s denial on March 7, 2012, of citizen petitions filed by AstraZeneca with regard to Seroquel tablets and Seroquel XR extended release tablets (quetiapine fumarate).

In the citizen petitions, AstraZeneca requested the FDA withhold finally approving any generic quetiapine product that omits from its labeling certain hyperglycaemia and suicidal warning language that the FDA required AstraZeneca to include in the labeling for its own Seroquel products. Data associated with the hyperglycaemia warning language at issue is protected by marketing exclusivity periods expiring as late as December 2, 2012. AstraZeneca also raised issues regarding data exclusivity rights granted to innovative companies that conduct new clinical trials.

AstraZeneca seeks 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 has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.

AstraZeneca said it will “vigorously defend its legal rights.”

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