Zostavax
zoster vaccine live (Oka/Merck)
Treatment for Herpes Zoster -- ProphylaxisFDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006
WHITEHOUSE STATION, N.J., February 24, 2006 - The U.S. Food and Drug Administration (FDA) is extending the review period for the Biologics License Application (BLA) for Zostavax (zoster vaccine live (Oka/Merck)), Merck's investigational shingles vaccine, to review additional information that Merck submitted during the review process. The FDA has informed Merck that the agency's new review goal date for the application for Zostavax is May 25.
Merck filed the BLA for Zostavax with the FDA on April 25, 2005. The Company has filed additional regulatory applications for Zostavax in other major markets including the European Union and Australia.
Source: Merck & Co., Inc.
Related Articles:
FDA Advisory Committee Agrees that Clinical Data Support the Efficacy and Safety of Zostavax, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older - December 15, 2005
Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax - June 29, 2005
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