October 29, 2009 Approval Letter - ProQuad

October 29, 2009

Our STN: BL 125108/341

Merck & Co., Inc.
Attention: Donna Zacholski
UG2D-68
P.O. Box 1000
North Wales, PA   19454-1099

Dear Ms. Zacholski:

We have approved your request to supplement your biologics license application for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®), to include concomitant administration with hepatitis A vaccine (VAQTA®) and/or pneumococcal conjugate vaccine (Prevnar®), use of ProQuad® in children 15 months to 12 years of age if a second dose of measles, mumps, rubella, and varicella is needed, additional safety data after a first or second dose of ProQuad®, and to comply with the Physician’s Labeling Rule format.  

This fulfills the following Postmarketing Commitments as stated in the September 6, 2005 approval letter.  

•           V221, Protocol 019-01 - ProQuad® Concomitant Use with Prevnar® (Pneumococcal 7-Valent Conjugate Vaccine, Wyeth-Lederle Vaccines).  The final study protocol will be submitted by September 2005.  The study will be initiated by February 2006.  The study will be completed by November 2007.
•           V251, VAQTA®+ ProQuad® Safety Study (Protocol 066).  The final study protocol will be submitted by October 2005.  The study will be initiated no later than May 2006.  The study will be completed by December 2007.
•           V251, Concomitant Use of VAQTA®, Prevnar®, and ProQuad® (Protocol 067).  The final study protocol will be submitted by October 2005.  The study will be initiated no later than April 2006.  The study will be completed by December 2007.

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, M.D.
Director
Division of Vaccines and Related Product Applications
Office of Vaccine Research and Review
Center for Biologics Evaluation and Research

Attachment:  Approved Final Draft Labeling