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Court Blasts FDA Over Pravachol Generic Launch

Law360 (October 24, 2005, 12:00 AM EDT) -- The FDA abused its discretion by triggering too early Teva Pharmaceutical Inc.’s 180-day market exclusivity for a generic cholesterol drug, according to a federal court’s order granting injunctive relief to the company.

In July, Israel-based Teva sued the U.S. Food and Drug Administration over a decision that effectively wiped out the company’s marketing exclusivity for pravastatin, the generic version of Bristol-Myers Squibb Co.'s Pravachol.

The suit, filed in the U.S. District Court for the District of Columbia, sought to reverse the FDA’s decision and enjoin the...
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