D.C. Circuit Upholds FDA Rule On 180-Day Exclusivity

Law360, New York (June 8, 2006, 12:00 AM EDT) -- In a move that could have far-reaching implications for generic drug makers, the U.S. Court of Appeals for the D.C. Circuit has upheld a controversial U.S. Food and Drug Administration rule that restricts the type of court decisions that can trigger the 180-day generic exclusivity period.

The court delivered its decision against Canadian generic drug maker Apotex Inc. earlier this week, determining that the arguments presented “adequately support FDA's position that an estoppel-based approach to the court decision trigger is ill-advised."

The decision marks the second...
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