Migraine Preventive Depakote - Generics Approved by FDA
The FDA announced yesterday the approval of the first generic versions of Depakote delayed-release (divalproex sodium). Depakote is FDA approved for Migraine prevention, seizure disorders, and bipolar disorder.
The generic divalproex sodium will carry the same black box warnings regarding:
- hepatic (liver) toxicity and failure
- birth defects
Gary J. Buehler, director of the FDA's Office of Generic Drugs commented,
"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... This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."
Eight companies have received approval to market divalproex sodium delayed-release tablets:
- Dr. Reddy's Laboratories, Hyderabad, India
- Genpharm Inc., Ontario, Canada
- Lupin Limited, Mumbai, India
- NuPharm Inc., Ontario, Canada
- Sandoz Inc., Broomfield, Colorado
- Sun Pharmaceutical Industries Ltd., Mumbai, India
- Upsher-Smith Laboratories, Maple Grove, Minnesota
- TEVA Pharmaceuticals USA, North Wales, Pennsylvania
Depakote is one of four medications that are FDA approved for Migraine prevention. The other three are:
- propranolol (brand name Inderal)
- timolol (brand name Blocadren)
- topiramate (brand name Topamax)
Those four medications, however, are not our only options for Migraine prevention. Many medications are prescribed off-label for this purpose. In fact, there are over 100 medications in use for Migraine and headache prevention. You can find more information and a full listing of these medications in Migraine preventive medications: too many options to give up!
FDA News. "FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder." July 29, 2008.
© Teri Robert, 2008