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

AstraZeneca today 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.

In the Citizen Petitions, AstraZeneca raised important issues regarding labelling requirements for generic copies of innovative medicines, as well as 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 2 December 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 will vigorously defend its legal rights.