GlaxoSmithKline announced that it received a FDA complete response letter with regards to its application for new drug status for Cervarix, a cervical cancer vaccine. A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval.
"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, M.D., Vice 
President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX(R) to the U.S. market."
Cervarix, one of the largest drug hopes in Glaxo's pipeline has already been approved in 45 countries and analysts had been expecting FDA approval by next month. The delay will result in a setback of at least a few months and possibly more than a year which will affect the company's intent to secure a market share from Merck's Gardasil which is already well established in the U.S.
Glaxo declined to comment as to when a final U.S. decision might be made.
[Source: PRNewsWire]
» GSK Answers FDA on Cervarix from PharmaGazette
GlaxoSmithKline (NYSE:GSK) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix.Cervarix, a vaccine for the prevention of cervical ... [Read More]
Tracked on: July 12, 2008 6:43 PM | Permalink to Trackback