FDA To Appeal Ruling On 180-Day Shared Exclusivity

Law360, New York (February 9, 2004, 12:00 AM EST) -- U.S. regulators are preparing an appeal of a recent court decision that barred the Food and Drug Administration from granting shared 180-day exclusivity to several makers of generic versions of branded drugs.

The FDA said it is working with the Justice Department on an appeal to the U.S. Court of Appeals for the District of Columbia of the decision that barred the agency from granting shared exclusivity to several generic makers of GlaxoSmithKline's antidepressant Paxil.

"Because the court's decision could have far-reaching implications for the public...
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