US FDA Approves Generic Versions Of Abbott’s 'Depakote'
Submitted by Carina Rose on Thu, 07/31/2008 - 10:44
The U.S. Food and Drug Administration, on Tuesday, approved several generic competitors to Abbott Laboratories' drug Depakote used for the treatment of seizures, bipolar disorder and migraine headaches.
With FDA’s approval, Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India, received approval to produce generic versions of the brand-name drug made by Abbott Laboratories.
“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,” Gary Buehler, director of the FDA’s Office of Generic Drugs, said in a news release.
The U.S. Food and Drug Administration ordered the companies manufacturing copied versions of the drug, known generically as divalproex sodium, to include strong warnings about the risk of liver damage and birth defects just as the brand version, which is prescribed for epilepsy.
The most severe side effects of Depakote are irreversible birth defects, such as births of brainless babies. Some if its side effects are mild and do not require medical attention. 1% to 10% of people experience weight gain and increased appetite. The more serious side effects include vomiting, loss of appetite, fever, or dark urine.
Shares of Abbott closed down 27 cents to end the day's trade on the New York Stock Exchange at $55.94.
