FDA Must Act Quickly On Ranbaxy Lipitor ANDA: Mylan

Law360, New York (April 28, 2011, 6:54 PM EDT) -- Mylan Pharmaceuticals Inc. asked a Washington federal judge on Thursday not to toss its suit seeking to compel the U.S. Food and Drug Administration to remove the exclusivity provision from Ranbaxy Laboratories Ltd.'s dormant first-filed abbreviated new drug application for Lipitor.

Ranbaxy, the first to challenge Pfizer Inc.'s patents on Lipitor when it filed its ANDA nine years ago, argues it has 180 days of exclusivity beginning in November to sell a generic version of the blockbuster cholesterol drug, known generically as atorvastatin. But Mylan, which...
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