DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
September 9, 2010
Our STN: BL 125108/435
Merck & Co., Inc.
Attention: Donna Zacholski
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 the following changes to the package insert:
- Update the package insert to add “aplastic anemia” to the list of post-marketing Adverse Events in Section 6.2 Post-Marketing Experience,
- Revision to Section 5.8 to include language regarding a report of secondary transmission without a rash based on post-marketing reports received for VARIVAX®.
- To include language in Section 5.8 “newborn infants less than 28 weeks of gestation regardless of maternal immune status” to the list of high-risk individuals susceptible to varicella.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.
This information will be included in your License Application File.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling