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September 12, 2013 Approval Letter - ZOSTAVAX
Our STNs: BL 103552/5882, 125123/1418 and 125108/682
Merck Sharp & Dohme Corp.
Attention: Donna Zacholski
P.O. Box 1000
North Wales, PA 19454-1009
Dear Ms. Zacholski:
We have approved your request to supplement your biologics license applications (BLAs) for both the refrigerator-stable and frozen formulations of Varicella Virus Vaccine Live (VARIVAX®), Zoster Vaccine Live (ZOSTAVAX®) and Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad®) manufactured at your West Point, PA facility, to revise information in the package inserts (in Highlights and section 8.1) regarding the Merck/CDC Pregnancy Registry for Varicella Zoster Virus (VZV)–Containing Vaccines. We also approve your proposed revisions to the PPI for Varicella Virus Vaccine Live (VARIVAX®) and Zoster Vaccine Live (ZOSTAVAX®).
We have received your request under 21 CFR 201.58 of June 9, 2013, for a waiver of the requirement in 21 CFR 201.57(c)(9)(i)(A) to describe teratogenic effect by a letter classification (A. B., C, or X). We grant this waiver, but note that you will continue to be required to appropriately describe the risks associated with the wild virus in the labeling.
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.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research