Zostavax
Generic name: zoster vaccine live
Treatment for: Herpes Zoster, Prophylaxis
FDA 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.
Posted: February 2006
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- Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax - June 29, 2005
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Zostavax (zoster vaccine live) FDA Approval History
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