Wednesday, 6 August 2008

FDA Approves First Generic Divalproex Sodium To Treat Seizures, Migraine Headaches And Bipolar Disorder

�The U.S. Food and Drug Administration approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.




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





Generic divalproex na will have the same safety warnings as Depakote, including a Boxed Warning that cautions about the risk of liver harm (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning besides highlights the risk of birth defects (teratogenicity), including neural tube defects.




The following firms have received approval to market divalproex sodium delayed-release tablets: Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy's Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India.




For more than information, see
Consumer Education: Generic Drugs.




Information on specific do drugs products nates be found on the Web site "Drugs@FDA"




http://www.fda.gov




View drug selective information on Depakote ER.



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