FDA OKs First Generic Depakote
Generic Depakote to Treat Seizures, Migraine Headaches, and Bipolar Disorder
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.