Endo and Vernalis provide update on Frova
17 August 2007
CHADDS FORD, Pa., and WINNERISH, U.K., Aug. 17, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP), and Vernalis pls (LSE: Ver) today announced that the U.S. Food and Drug Administration has requested an extension of the
August 19, 2007 review date in order to have more time to review the supplemental New Drug Application for FROVA® (frovatriptan succinate) 2.5 mg tablets for the additional indication as short-term (six days) prevention of menstrual migraine.
The FDA indicated that it will provide a revised timeline to Endo and Vernalis, and the companies will make an announcement when appropriate. Until the companies receive further information from the FDA, they intend to continue with their existing commercial plan. The FDA has not currently requested any additional information or clinical trial data. |
