On 29th of July 2008 FDA has approved the new Divalproex Sodium tablets. This is the first Generic version of Depakote tablets.
These tablets are specially made to cure seizures, bipolar disorder and migraine headaches.
Along with the approval FDA has given the same safety warning to the Divalproex Sodium tablet as given to Depakote tablet. The warning given to divalproex sodium tablet is “Black Box” warning –the FDA’s sternest warning. This cautions about the risk of the liver damage (hepatoxicity), inflamated pancreas (pancreatitis) risk of birth defects and neural tube defects.
Sun Pharmaceutical Industries Ltd. of Mumbai, India, Genpharm Inc. of Ontario, Canada, Nu-Pharm Inc. of Ontario, Canada, Upsher-Smith Laboratories of Maple Grove, Minn., Sandoz Inc. of Broomfield, Colo., Teva Pharmaceuticals USA of North Wales, Pa., Dr. Reddy’s Laboratories of Hyderabad, India, and Lupin Limited of Mumbai, India are the firms which has been approved by FDA to market this drug.
Source: WebMDHealth
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