Divalproex goes generic
Executive Summary
FDA approved the first generic version of Depakote delayed-release tablets (divalproex sodium) for the treatment of seizures, bipolar disorder and migraine headaches, July 29. Eight firms, most outside the U.S., have received approval to market divalproex tablets: Sun, Dr. Reddy's, Lupin, Genpharm, Nu-Pharm, Upsher-Smith, Sandoz and Teva. Depakote is currently caught up in FDA's investigation into the risk of suicidiality with anti-epileptics drugs, although it has less risk than other drugs in the class (1"The Pink Sheet," July 14, 2008, p. 3)