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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 29, 2011 Approval Letter - Varivax

Our STN: BL 103552/5613

 
Merck Sharp & Dohme Corp.
Attention: Annie Sturgess, Ph.D.                              
WP37A-102                                                   
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.
                                                                        Director
                                                                        Division of Viral Products
                                                                        Office of Vaccine
                                                                         Research and Review  
                                                                        Center for Biologics
                                                                         Evaluation and Research
 
Attachment: Approved Final Draft Labeling