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FDA Information

Divalproex, formally know as divalproex sodium and more commonly known by its brand name DepakoteŽ, was first approved by the United States Food and Drug Administration (FDA) in 1983 for the treatment of epilepsy.

More recently, on May 10th 2006, the United States Food and Drug Administration (FDA) approved safety labeling revisions to advise of the risk for fetal harm associated with use of divalproex sodium-coated particles in capsules during pregnancy, as well as the risk for hyperammonemia with or without encephalopathy in patients treated with divalproex sodium who receive concurrent topiramate therapy.

 

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