FDA Forced To Review Cholesterol Drug Exclusivity

Law360, New York (March 16, 2006, 12:00 AM EST) -- Departing from a lower court ruling, the U.S. Court of Appeals for the District of Columbia Circuit has demanded that the U.S. Food and Drug Administration revisit the issue of generic exclusivity, after a contentious decision involving cholesterol drug Pravachol.

On Thursday, the court reversed a federal district court decision that had granted Teva Pharmaceuticals Inc. six months to exclusively market pravastatin, the generic version of Bristol-Myers Squibb Co.’s Pravachol.

Last July, Israel-based Teva sued the FDA over an earlier decision that effectively wiped out this...
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