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news.The FDA has informed MedImmune that it will need more information before it can approve the company's application for a new version of its FluMist nasal spray flu vaccine.
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The new version of the drug, known as CAIV-T, can be stored in refrigerated conditions, an improvement over the current form of FluMist which must be kept frozen. The added convenience provided by the refrigerated version of the product could help to increase uptake of the drug which was first approved by the FDA in 2003.
“Based on our review of the letter received, we expect to fully respond to the agency within two to four weeks,” said Linda Peters, senior vice president, regulatory affairs. “We are confident that our continued interaction with the FDA will result in approval of the new formulation of our intranasal vaccine in advance of the 2007-2008 influenza season.”