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.
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.
A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval.
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.
A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval.
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