FDA Informs Endo and Vernalis That New Target Action Date on Frova(R) sNDA Is Sept. 30, 2007
Finally... (I hope).
CHADDS FORD, PA and WINNERISH, UK--(MARKET WIRE)--Sep 10, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NasdaqGS:ENDP - News), and Vernalis plc (LSE:VER.L - News) today announced that the U.S. Food and Drug Administration has informed the companies that it is now targeting September 30, 2007 as the date for issuing an action letter for the supplemental New Drug Application for FROVA® (frovatriptan succinate) 2.5 mg tablets. As previously disclosed, the FDA requested an extension of the August 19, 2007 review date to have more time to review the sNDA for the additional indication as short-term (six days) prevention of menstrual migraine.
Also as previously noted, Endo and Vernalis intend to continue with their existing commercial plan, which includes commercial launch in January 2008 if the sNDA is approved... |
