FDA Approves First Generic Divalproex Sodium
Like name-brand Depakote, generic versions will come with warnings on liver damage, pancreatitis
WEDNESDAY, July 30 (HealthDay News) -- The U.S. Food and Drug Administration has approved generic versions of Depakote delayed-release tablets (divalproex sodium) for the first time, according to a press release issued by the FDA this week.
Depakote is used for the treatment of seizures, bipolar disorder and migraines. The FDA has given several U.S. and international companies approval to market the generic versions.
The packaging for generic divalproex sodium will include the same safety warnings found on name-brand Depakote packaging, including a boxed warning about the risk of liver damage, including fatalities, and pancreatitis, including fatal cases. The boxed warning also highlights the risk of birth defects, including neural tube defects.
"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."