• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

?
-

Resources for You

December 11, 2012 Approval Letter-Varivax

 

Our STN: BL 103552/5548
 
Merck Sharp & Dohme Corp.
Attention:  Donna Zacholski
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1009
 
Dear Ms. Zacholski:
 
We have approved your request to supplement your biologics license application (BLA) for both the refrigerator-stable and frozen formulations of Varicella Virus Vaccine Live (VARIVAX®), to include revised labeling in Physician Labeling Rule (PLR) format submitted under section 351 of the Public Health Service Act (42 U.S.C. 262).
 
We have reviewed your request under 21 CFR 201.58 of November 8, 2012, for waiver of the requirement in 21 CFR 201.57(d)(8) that the Highlights section of the full prescribing information not exceed one-half page. We grant this waiver.
 
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
 
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.
 
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.  You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
 
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 or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
 
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.
 
We will include the information contained in the above referenced supplement in your BLA file.
 
Sincerely yours,
 
 
Wellington Sun, M.D.
Director
Division of Vaccines and
  Related Products Applications
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research
 
Attachment: Approved Final Draft Labeling