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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 30, 2010 Approval Letter - VAQTA

March 30, 2010

Our STN:  BL 103606/5374

Merck & Co., Inc.
Attention:  Stella I. Reed, Ph.D.
UG2D-68
P.O. Box 1000
North Wales, PA 19454-1099

Dear Dr. Reed:

We have approved your request to supplement your biologics license application for hepatitis A vaccine (VAQTA®) to include the following:

  • Concomitant administration with Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®) and pneumococcal conjugate vaccine (Prevnar®);
  • A statement in Section 14.4 of the package insert (PI) on Duration of Immune Response to extend the duration of immunity out to 10 years post-vaccination; and
  • Revisions to the PI to comply with the Physician’s Labeling Rule format.    

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate.  Please provide content of labeling in Structured Product Labeling format.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

--signature--

Wellington Sun, MD
Division Director
Division of Vaccines and
Related Product Application
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling