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...

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 (Also see "FluMist Comparison To Inactivated Vaccine Suggested By FDA Committee" - Pink Sheet, 23 Dec, 2002.), p. 23). MedImmune expects a second quarter approval....