FDA approves generic divalproex sodium

July 31, 2008

The generic version will carry the same warnings as Depakote.

A generic version of Depakote delayed-release tablets (divalproex sodium), used to treat seizures, bipolar disorder, and migraine headaches, was approved this week by the Food and Drug Administration. "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 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." The generic version will carry the same warnings as Depakote (Abbott Laboratories), cautioning against the risk of liver damage and pancreatitis. Separately, Noven Pharmaceuticals reported that its Stavzor (valproic acid delayed-release capsules) has received FDA approval. Like divalproex sodium, Stavzor is also indicated for treating bipolar disorder, seizures, and migraines. However Stavzor is not interchangeable with Depakote. Rather, Stavzor comes in soft gel capsules that are 40% smaller than Depakote and Depakote ER tablets at the 500-mg dosage strength.

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