Lupin Ltd, Sun Pharma and Dr Reddy's get US FDA approval for generic Depakote delayed-release tablets
31 Jul 2008
Three Indian companies, Lupin Limited, Sun Pharmaceutical Industries and Dr. Reddy's Laboratories have received final approval for first generic versions of Depakote delayed-release tablets (DivaJproex Sodium Delayed-Release Tablets,), from the U.S. Food and Drug Administration (USFDA).
The drug is used for the treatment of epilepsy, migraine headaches, seizures and bipolar disorder.
IMS Health sales data showed Depakote sales for twelve months ended March 2008 were approximately to the tune of $803 million.
The approval is for generic versions of divalproex sodium delayed release in milligrams of 125 mg, 250 mg and 500 mg. Divalproex sodium de1ayed-re1ease tablets are the AB-rated generic equivalent of Abbott Laboratories' Depakote» tablets
Gary J. Buehler, director of the US FDA's Office of Generic Drugs said, "Generic drugs undergo a rigourous 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."
Depakote's safety warnings will be incorporated for generic divalproex sodium which includes Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases and also highlights the risk of birth defects (teratogenicity), including neural tube defects.
