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Court dismisses AstraZeneca case against FDA

Drug maker had sought injunction against FDA approval of Seroquel generics

NEW YORK — A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

The U.S. District Court for the District of Columbia dismissed AstraZeneca's lawsuit against the Food and Drug Administration over generic formulations of Seroquel (quetiapine fumarate) and its extended-release version, Seroquel XR. The roots of the lawsuit go back to September 2011, when the drug maker asked the agency to withhold approval of any generic version of the drug whose labeling didn't include warning language about risks of elevated blood sugar and suicide that it had required AstraZeneca to include.

The FDA turned down AstraZeneca's request on March 7, prompting the company to sue the agency five days later. The company had requested an injunction against the FDA's approval of any generic version of Seroquel until the Dec. 2, 2012 expiration of clinical trial data.

"Notwithstanding the court’s decision, the company continues to believe strongly in the merits of its position and is evaluating its options," a statement by AstraZeneca read.


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