First Generic Versions of Depakote Win FDA Approval

The U.S. Food and Drug Administration on Tuesday approved the first generic versions of Depakote (divalproex sodium) for treating epileptic seizures, migraine headaches and bipolar disorder, the health agency announced.

In all, 8 pharmaceutical manufactures;

• Teva Pharmaceutical Industries Ltd,
• Novartis AG's Sandoz unit,
• Sun Pharmaceutical Industries Ltd.,
• Dr. Reddy's Laboratories Ltd.,
• Lupin Limited in India,
• Genpharm Inc in Canada
• Nu-Pharm Inc in Canada
• Minnesota-based Upsher-Smith Laboratories

are granted license to produce generic versions of the brand-name drug already manufactured by Abbott Laboratories.

In addition, the cheaper versions will carry similar label warnings as the brand-name medication, including a "black box" warning -- the FDA's sternest warning – cautioning about the risk of liver damage (hepatoxicity), inflamed pancreasdefine (pancreatitis) and neural tube defects, the agency marked.

"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, director of the FDA's Office of Generic Drugs stated in a FDA news release.

"This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder, and migraines," he ensured.