Merck's FDA review date for investigational shingles vaccine extended

By Elaine Rigoli

Tampa, Fla., Feb. 24 - The Food and Drug Administration is extending the review period for the Biologics License Application for Zostavax (zoster vaccine live), 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, according to a company news release.

The company said it has filed additional regulatory applications for Zostavax in other major markets including the European Union and Australia.

Merck develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company is based in Whitehouse Station, N.J.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.