L’FDA ha aggiunto in data 19 ottobre 2018, la “meningite” come effetto collaterale del vaccino VARIVAX (varicella singolo) a seguito delle segnalazioni di reazioni avverse post marketing.
Our STN: BL 103552/6113
Merck Sharp & Dohme Corp. Attention: Louise Parks Saldutti, Ph.D. 351 N. Sumneytown Pike
P.O. Box 1000
North Wales, PA 19454
Dear Dr. Saldutti:
October 19, 2018
We have approved your request dated April 20, 2018, to supplement your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Varicella Virus Vaccine Live (VARIVAX) manufactured at your West Point, Pennsylvania (b) (4) facilities to revise the packageinsert to include the term “meningitis” in Section 6.2 Post-Marketing Experience and to clarify previously reported terms of “encephalitis” and “herpes zoster.”
We hereby approve the draft package insert labeling submitted under amendment 103522/6113/5000 dated October 17, 2018.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, please submit the final content of labeling (21 CFR 601.14) in Structured Product Labeling (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 SPL Standard for Content of Labeling Technical Qs and As athttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/G uidances/UCM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
PACKAGE AND CONTAINER LABELS
Please electronically submit final printed package and container labels that are identical to the package and container labels submitted on April 20, 2018 according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993www.fda.gov
Page 2 – STN 103552/6113– Louise Parks Saldutti, Ph.D.
the eCTD Specifications at https://www.fda.gov/downloads/drugs/guidancecompliance
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 Form FDA 356h.
ADVERTISING AND PROMOTIONAL LABELING
You may submit two draft copies of the proposed introductory advertising and promotional labeling with Form FDA 2253 to the Advertising and Promotional Labeling Branch at the following address:
Food and Drug Administration
Center for Biologics Evaluation and Research Document Control Center
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
You must submit copies of your final advertising 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 reised labeling incorporating a revised content of labeling that include these changes.
We will include information contained in the above-referenced supplement in your BLA file.
Doran L. Fink, M.D., Ph.D. Deputy Director – Clinical Division of Vaccines and
Related Products Applications Office of Vaccines
Research and Review Center for Biologics
Evaluation and Research