FDA Gets Mylan Suit Over Generic Lipitor Tossed

Law360, New York (May 2, 2011, 9:03 PM EDT) -- A federal judge in Washington on Monday tossed Mylan Pharmaceuticals Inc.'s suit to compel the U.S. Food and Drug Administration to weigh in on Ranbaxy Laboratories Ltd.'s exclusivity provision for marketing a generic version of Lipitor.

Mylan, which filed its own application with the FDA to market a Lipitor generic known as atorvastatin, has no standing to push the agency to act on a competitor's application, U.S. District Judge James E. Boasberg said in his opinion.

The FDA's decision could be lucrative to the company that...
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Case Information

Case Title

MYLAN PHARMACEUTICALS INC. et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION


Case Number

1:11-cv-00566

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

James E. Boasberg

Date Filed

March 18, 2011

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