Bloomberg News

AstraZeneca Sues FDA Over Generic Seroquel Warning Denial

March 13, 2012

AstraZeneca Plc (AZN) sued the U.S. Food and Drug Administration, seeking to overturn the regulator’s denial of a request that generic copies of its Seroquel antipsychotic come with warnings about high blood sugar and suicidal tendencies.

AstraZeneca is seeking an injunction barring the FDA from approving copies of Seroquel until Dec. 2, when exclusivity expires on clinical trial data that show a link between Seroquel and hyperglycemia, or until a federal court has a “meaningful opportunity to review imminent FDA action,” the London-based company said in a statement today.

The FDA on March 7 denied two so-called Citizen Petitions filed by the U.K. drugmaker on Sept. 9 that asked the regulator to withhold final marketing approval for generic versions of Seroquel, also known as quetiapine fumarate, that omit mentioning the risks, AstraZeneca said.

To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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