FDA OKs Generic Version Of Abbott's Tricor By Impax, Teva

Law360, New York (March 8, 2004, 12:00 AM EST) -- The U.S. Food and Drug Administration has granted generic drug makers Impax Laboratories and Teva Pharmaceuticals a tentative approval for their copycat versions of Tricor tablets for cholesterol reduction, Impax and Teva said Monday.

Both companies are involved in litigation with the drug’s originator, Abbott Laboratories, over their applications for the right to make Fenofibrate tablets.

Final FDA approval is contingent upon the earlier of the resolution of pending patent-infringement litigation, or the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration...
To view the full article, register now.