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US Court Dismisses AstraZeneca's Case Against FDA - Update

US Court Dismisses AstraZeneca's Case Against FDA - Update
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Drugmaker AstraZeneca Plc (AZN: Quote,AZN.L) on Monday said a federal district court dismissed without prejudice on Friday its request for a preliminary injunction in a lawsuit against the US Food and Drug Administration regarding final marketing approval of generic quetiapine, sold under the brand name Seroquel.

The company filed the lawsuit with the US District Court for the District of Columbia on March 12 seeking to overturn the U.S. regulators' denial of a bid to delay the entry of generic versions of its antipsychotic blockbuster Seroquel. The patent covering the active ingredient in the drug expired in September last year and pediatric exclusivity expires this month.

Early this month, the FDA had denied the company's Citizen Petitions requesting that the regulator withhold finally approving any generic with labeling that omits certain hyperglycemia warnings required in the labeling for Seroquel (quetiapine fumarate) tablets and Seroquel XR extended-release tablets.

It was on September 9, 2011 that AstraZeneca filed the Citizen Petition with the FDA for both Seroquel and Seroquel XR. According to the company, data associated with the hyperglycemia warning language at issue is protected by marketing exclusivity periods expiring as late as December 2, 2012.

Notwithstanding the court's decision, the Anglo-Swedish company said today it continues to believe strongly in the merits of its position and is evaluating its options.

AZN closed on Friday at $45.18, down $0.12 or 0.26 percent, on a volume of 1.58 million shares. The stock is currently down 7 pence on the LSE at 2,833 pence.

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by RTT Staff Writer

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