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U.S. judge blocks FDA rule allowing generic versions of Hospira drug

By Brendan Pierson

(Reuters) - A federal judge has issued a temporary restraining order against the U.S. Food and Drug Administration's decision to allow the sale of generic versions of the Hospira Inc sedative Precedex.

Hospira filed a lawsuit in U.S. District Court in Maryland on Tuesday asking for a temporary restraining order against the FDA, saying the agency's decision to allow generic Precedex went against its own rules.

The FDA said Monday that drugmakers could sell generic Precedex as long as the label left out information about uses of the drug covered by Hospira's patent, which covers "intensive care unit sedation."

U.S. District Judge Jarrod Hazel said in his order on Tuesday that Hospira was likely to win its suit because the FDA's decision was "at odds with relevant authority" and "tantamount to a change of the rules."

The judge said that allowing such a change could cause people to lose faith in the process for approving drugs.

Mylan Inc, a drug company that had already won FDA approval to make generic Precedex, joined the lawsuit on the FDA's side on Tuesday, arguing that it would be harmed by a temporary restraining order.

However, Judge Hazel found that any harm to Mylan or other generic drugmakers "would pale in comparison" to the harm Hospira would suffer without the restraining order. Hospira said in its lawsuit that it would lose "tens of millions of dollars" if the FDA's decision was not overturned.

Precedex accounted for 11 percent of Hospira's global net sales of $4.1 billion in 2013, according to the company's most recent annual report.

Sandoz Inc, the generic arm of Swiss drugmaker Novartis AG, was set to start selling generic Precedex in December under a settlement of patent litigation with Hospira. According to court papers, Sandoz expected to have an exclusive right to sell the generic drug for six months.

Sandoz intervened in Hospira's suit against the FDA on Tuesday, arguing that it would be wrongly deprived of the six-month exclusivity period if the FDA's decision was allowed to stand.

An FDA representative declined to comment. Mylan, Hospira and Sandoz did not immediately return requests for comment.

The case is Hospira v. Burwell, U.S. District Court, District of Maryland, No. 8:14-cv-02662.

(Reporting by Brendan Pierson; Editing by Ted Botha and Dan Grebler)

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