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Hospira sues U.S. FDA over approval of generic sedative

Started by riky, August 20, 2014, 09:00:29 AM

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riky

Hospira sues U.S. FDA over approval of generic sedative

Drugmaker Hospira Inc has sued the Food and Drug Administration over its decision to open the doors for competitors to sell generic versions of its patented sedative, Precedex. The suit, filed Tuesday in federal court in Maryland, claimed the FDA's "arbitrary and capricious" decision on Monday effectively changed the rules for generic drugs while sidestepping the normal rule-making process. Hospira is asking the court to issue a temporary restraining order blocking the sale of any generic Precedex. According to the suit, the FDA has already granted an application by one company, Par Sterile Products, to make the drug.

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