Generic Depakote ER and new Frova indication
@trobert Health Guide
Mylan Pharmaceuticals has received tentative approval from the FDA to sell a generic version of Depakote ER, owned by Abbott Laboratories. This is the extended-release formulation of divalproex sodium, which is FDA-approved for Migraine prevention. The tentative approval is for 250 and 500mg tablets. Don't expect to find it in your pharmacies until 2008, however, as Abbott's patent doesn't expire until January, 2008.
Some of you may know that there have been studies using Frova (frovatriptan) as a preventive for menstrually-triggered Migraines. Endo Pharmaceuticals and Vernalis plc, manufacturers of Frova, have sumbitted a Supplemental New Drug Application to the FDA to add a new indication to the labeling of Frova for short-term prevention of menstrual Migraine. The original date for the completion of the review was May 19, 2007. That has now been extended to August 19, 2007.
Published On: March 16, 2007