FDA is extending the user fee date for Merck's zoster vaccine Zostavax by three months to May 25 in order to review additional information provided by the firm, Merck said Feb. 24.

The BLA for Zostavax was filed April 25, 2005, giving it an original user fee date of Feb. 23.

The agency's Vaccines & Related Biological Products Advisory Committee unanimously agreed at its Dec. 15, 2005 meeting that the shingles vaccine is safe and effective for adults over 60 (¹ Also see "Merck Zostavax Shingles Vaccine Safe and Effective For Adults Over 60, Committee Says" - Pink Sheet, 15 December, 2005.).

Zostavax User Fee Date Extended To May

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