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www.fdanews.com/articles/61086-endo-and-vernalis-announce-the-filing-of-snda-for-frova

ENDO AND VERNALIS ANNOUNCE THE FILING OF SNDA FOR FROVA

July 21, 2006

Endo Pharmaceuticals and Vernalis announced that Endo has submitted to the FDA a supplemental new drug application (SNDA) for Frova (frovatriptan succinate) 2.5-mg tablets for the short-term (six days per month) prevention of menstrual migraines.

If the SNDA is approved, Frova will be the only triptan indicated in the U.S. for the prevention of menstrual migraines. Currently, the drug is approved for the treatment of acute migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.