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From Earlier: AstraZeneca Files Lawsuit against the FDA for Decision Regarding Quetiapine Product Labeling and Exclusivity

By Insider Scoop
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Courtesy of Benzinga.

AstraZeneca (NYSE: AZN) today announced that it has 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 March 7, 2012 of the company’s Citizen Petitions with regard to SEROQUEL® (quetiapine fumarate) tablets and SEROQUEL XR® (quetiapine fumarate) extended release tablets.

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.

(c) 2011 Benzinga.com. All rights reserved. This material may not be published in its entirety or redistributed without the approval of Benzinga.


For more Benzinga, visit Benzinga Professional Service, Value Investor, and Stocks Under $5.

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