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First Generic Versions of Depakote Approved

TUESDAY, July 29 -- The first generic versions of Depakote (divalproex sodium) have been approved by the U.S. Food and Drug Administration to treat epileptic seizures, migraine headaches and bipolar disorder, the agency said Tuesday.

Eight firms were granted license to produce generic versions of the brand-name drug made by Abbott Laboratories. The generics will have the same label warnings as the brand-name medication, including cautions about increased risk of severe liver damage, inflamed pancreas, and neural tube birth defects.

"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," Gary Buehler, director of the FDA's Office of Generic Drugs, said in an agency news release.

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Posted: July 2008