FDAnews Drug Daily Bulletin

FDA Gives Thumbs Up to Generic Seizure Drug

Aug. 7, 2008

The FDA has approved the first generic versions of Abbott’s Depakote delayed-release tablets, 125, 250 and 500 mg.

The generic tablets will have the same safety warnings as Depakote (divalproex sodium), including a boxed warning that cautions about the risk of liver damage and pancreatitis, according to the FDA. The warning also will highlight the risk of birth defects.

Sun Pharmaceutical, Genpharm, Nu-Pharm, Upsher-Smith Laboratories, Sandoz, Teva Pharmaceuticals USA, Dr. Reddy’s Laboratories and Lupin Limited all received approval to market the generic drug.

Depakote is approved by the FDA to treat seizures, bipolar disorder and migraine headaches. Sales of the drug were strong in the second quarter, earning $414 million worldwide, according to Abbott.