Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

September 29, 2011 Approval Letter - Varivax

Our STN: BL 103552/5613

Merck Sharp & Dohme Corp.
Attention: Annie Sturgess, Ph.D.                              
P.O. Box 4
West Point, PA 19486-0004
Dear Dr. Sturgess:
We have approved your request to supplement your biologics license application for Varicella Virus Vaccine Live (VARIVAX®), to extend the storage time for the Frozen Formulation from  ------(b)(4)------ when stored at 2°C to 8°C in support of the implementation of new shipping containers that use frozen gel packs instead of dry ice as the refrigerant, to revise the labeling to reflect the extended storage time, and to reduce the in-house ≤ (b)(4) storage time from --(b)(4)-- to --(b)(4)--.
We will include information contained in the above-referenced supplement in your biologics license application file.
                                                                        Sincerely yours,
                                                                        Jerry P. Weir, Ph.D.
                                                                        Division of Viral Products
                                                                        Office of Vaccine
                                                                         Research and Review  
                                                                        Center for Biologics
                                                                         Evaluation and Research

Resources for You

Page Last Updated: 10/04/2011
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English