Wyeth FluMist Draft Label Will Be Reviewed By CDC Cmte. To Speed Coverage
Executive Summary
Wyeth has obtained permission from FDA to provide draft labeling for its intranasal flu vaccine FluMist to CDC's Advisory Committee on Immunization Practices in order to speed a coverage decision once the product is approved
You may also be interested in...
FluMist Pharmacy Administration In 36 States Upon Approval – MedImmune
MedImmune expects pharmacists in 36 states to administer FluMist to patients upon launch of the intranasal flu vaccine, President Melvin Booth said
FluMist Pharmacy Administration In 36 States Upon Approval – MedImmune
MedImmune expects pharmacists in 36 states to administer FluMist to patients upon launch of the intranasal flu vaccine, President Melvin Booth said
MedImmune FluMist “complete response”
MedImmune issues response to third "complete response" letter for intranasal flu vaccine FluMist Feb. 7. FDA outlined five questions in its Jan. 29 letter: one labeling clarification; three technical clarifications; and a fifth question on postmarketing studies. FluMist, which is co-developed with Wyeth, has been under review since October 2000. FDA's Vaccine & Related Biological Products Advisory Committee recommended approval for healthy patients between five and 49 years of age (1"The Pink Sheet" Dec. 23, 2002, p. 23). MedImmune expects a second quarter approval...