FDA Generics Process Not Bound By 'Fairness,' DC Circ. Told

Law360, New York (February 5, 2013, 4:25 PM EST) -- The U.S. Food and Drug Administration on Friday urged the D.C. Circuit to reverse a court order forcing it to approve a generic medication produced by Watson Laboratories Inc., saying the ruling was grounded not in law but rather in vague notions of “fairness.”

In its brief, the FDA argued that a district judge blocked its decision to deny 180-day marketing exclusivity to Watson for a version of diabetes drug Actos and instead grant it to Mylan Pharmaceuticals Inc. solely because the outcome seemed inequitable....
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