July 29, 2008 -- The FDA today approved the first generic version of Depakote (divalproex sodium) delayed-release tablets. Depakote is approved by the FDA to treat seizures, bipolar disorder, and migraine headaches.
"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient the same amount of high-quality, safe, and effective drug as the name-brand product," Gary J. Buehler, RPh, director of the FDA's Office of Generic Drugs, says in an FDA news release. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder, and migraines."
Generic divalproex sodium will have the same safety warnings as Depakote, including a "black box" warning -- the FDA's sternest warning -- that cautions about the risk of liver damage (hepatoxicity) and inflamed pancreas (pancreatitis), including fatal cases of both. The boxed warning also highlights the risk of birth defects, including neural tube defects.
The FDA has approved the following firms to market divalproex sodium delayed-release tablets: 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.