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Hospira (HSP) Sues FDA Over Generic Precedex Decision

August 19, 2014 9:07 AM EDT

Hospira (NYSE: HSP) confirms its earnings per share guidance of $2.30 - $2.50 for calendar year 2014 as reflected and discussed in its second quarter 2014 earnings call and press release, which was furnished as an exhibit to its Current Report on Form 8-K dated July 30, 2014.

On August 18, 2014, the U.S. Food and Drug Administration (the “FDA”) posted its decision on the docket it opened on January 15, 2014 concerning potential label carve outs proposed by filers for a generic form of Precedex. The docket is located at http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FDA-2014-N-0087. Based on this decision, the FDA has approved applications for generic Precedex™ products and appears poised to grant additional generic applications.

On August 19, 2014, Hospira filed against the FDA a lawsuit in federal court, Hospira v Burwell, et al. Case 8:14-cv-02662-GLH in the United States District Court for the District of Maryland, challenging the FDA’s decision as set forth above.



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