MedImmune refrigerated FluMist clears FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
MedImmune is planning its own February thaw as it gears up to stop producing the frozen formulation of its intranasal influenza vaccine FluMist in favor of the newly-approved refrigerator-stable formulation when manufacturing begins next month, the company says. MedImmune announced FDA approval of the new FluMist formulation, also known as CAIV-T (cold adapted influenza vaccine, trivalent), for "healthy children and adults 5 years to 49 years of age" on Jan. 8. An indication for use in children ages 1 to 5 years has an estimated late-May user fee goal. MedImmune expects to manufacture 7 to 10 million doses of the new formulation, which is easier to distribute and store, for the 2007/2008 flu season - two to three times the 3 million doses of frozen FluMist manufactured for the 2006/2007 season. The fridge formulation will also be priced at a slight discount to the older version. FDA issued a "complete response" letter for refrigerated FluMist in July (1Pharmaceutical Approvals Monthly August 2006, p. 32); MedImmune responded Aug. 11, 2006 with additional information on bridging studies for both versions...
You may also be interested in...
Fridge-stable FluMist gets "complete response"
MedImmune says it continues to expect its refrigerator-stable formulation of FluMist (intranasal influenza vaccine live) will reach the market in time for the 2007-2008 flu season after receiving a "complete response" letter July 18. FDA is requesting clarification and additional information on the new formulation, which the company submitted July 28. MedImmune is seeking approval to switch formulations from frozen FluMist, indicated in healthy individuals 5 to 49 years of age, to the refrigerator-stable cold adapted influenza vaccine, trivalent (CAIV-T). MedImmune announced July 31 that it has submitted a FluMist sBLA to expand the treatment population down to pediatrics in the 12 to 59-month age range...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.