AstraZeneca sues US FDA over Seroquel decision

Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced this morning that it has filed a law suit against the US Food and Drug Administration in the US District Court for the District of Columbia to overturn the FDA's denial on last week of the company's Citizen Petitions with regard to its antipsychotic drugs Seroquel (quetiapine fumarate) tablets and Seroquel XR extended release tablets (The Pharma Letter March 9).

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.

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 will vigorously defend its legal rights.