FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches
and Bipolar Disorder
The U.S. Food and Drug Administration today 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 divalproex sodium will have the same safety warnings as Depakote,
including a Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and
pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning also highlights the risk of birth defects
(teratogenicity), including neural tube defects. Read more...
