July 30, 2008

FDA OKs Generic Depakote

The U.S. Food and Drug Administration has approved the first generic versions of a drug designed to treat seizures, bipolar disorders and migraine headaches.

The FDA said the generic versions of the drug Depakote (divalproex sodium) will carry the same warnings as Depakote.

Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product, said Gary Buehler, director of the FDA's Office of Generic Drugs. This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines.

Generic divalproex sodium will include a warning that cautions about the risk of liver damage and pancreatitis, both of which include fatalities. The warning also highlights the risk of birth defects.

The companies approved to market divalproex sodium delayed-release tablets are: Sun Pharmaceutical Industries Ltd. and Lupin Ltd., both of Mumbai; Genpharm Inc. and Nu-Pharm Inc., both of Ontario, Canada; Upsher-Smith Laboratories of Maple Grove, Minn.; Sandoz Inc. of Broomfield, Colo.; TEVA Pharmaceuticals USA of North Wales, Pa.; and Dr. Reddy's Laboratories of Hyderabad, India.


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