Article: Endo and Vernalis plc Announce Three-Month Extension of PDUFA Date for Frova sNDA.

Article: Market Gainer Issues Update On Vernalis plc.
M2 Presswire;  May 8, 2006 ;     700+ words ... ... marketgainer.com: Market Gainer Issues Update On Vernalis ... LTD RDATE:08052006 Market Gainer is quickly emerging as ... III efficacy study of Frova (frovatriptan succinate ... additional indication of Frova for the prevention of ...

Article: Frova(R) Meets Primary Endpoint in Second Phase III Study ...
PR Newswire;  May 8, 2006 ;     700+ words ... ... the second Phase III efficacy study of Frova(R) (frovatriptan succinate) 2.5 ... approval for the additional indication of Frova(R) for the prevention of menstrual migraine. If approved, Frova(R) will be the only triptan indicated ...

Article: Vernalis plc Announces FDA Acceptance for Filing of ...
PR Newswire;  September 20, 2006 ;     700+ words ... ... supplemental New Drug Application (sNDA) for Frova(R) (frovatriptan succinate) 2.5 ... needed to assess the safety and efficacy of Frova(R) for the short-term prevention of ... Gregory Gin Notes to Editors The sNDA for Frova(R) is supported by data from four studies ...

Article: Endo Licenses Rights from Vernalis to Market Acute Migraine ...
PR Newswire;  July 14, 2004 ;     700+ words ... ... exclusive rights to market Vernalis's Frova(TM) (frovatriptan) in North America. Launched in the U.S. in June 2002, Frova(TM) is indicated for the acute treatment ... migraine headaches in adults. Net sales of Frova(TM) in the U.S. were $37.5 million ...

Article: Elan and UCB Announce Agreement to Co-Promote New Migraine Drug ...
PR Newswire;  March 28, 2002 ;     700+ words ... ... to co-promote the new migraine drug FROVA (frovatriptan succinate) in the United States. Elan and UCB will launch FROVA in the second quarter of 2002. Under ... promotion agreement, UCB will co-promote FROVA with Elan to neurologists using their ...

Article: FDA Approves Elan's Migraine Drug Frova(TM) (frovatriptan ...
PR Newswire;  November 9, 2001 ;     700+ words ... ... Food and Drug Administration approved Frova(TM) (frovatriptan succinate) 2.5 ... Elan commented, "The FDA's approval of Frova is a key milestone in advancing our pipeline ... patients who suffer from migraine headaches, Frova, a new medicine for migraine. We are ...

Article: Endo licenses rights to market acute migraine treatment ...
Medical Letter on the CDC & FDA;  August 15, 2004 ;     700+ words ... ... exclusive rights to market Vernalis's Frova (frovatriptan) in North America. Launched in the U.S. in June 2002, Frova is indicated for the acute treatment ... migraine headaches in adults. Net sales of Frova in the U.S. were $37.5 million ...