Our STN: BL 125020/2193
MedImmune Vaccines, Inc.
Attn: Nancy R. Kavanaugh, Ph.D.
One MedImmune Way
Gaithersburg, MD 20878
Dear Dr. Kavanaugh:
We have approved your request to supplement your biologics license application for
Influenza Vaccine Live, Intranasal (FluMist®) manufactured at your Liverpool facility in the United Kingdom, to revise labelling as follows:
- NDC for individual unit dose (sprayer) is added to Section 16.1 (How Supplied) of the package insert.
- Temperature conversion for 25 degrees Celsius to 77 degrees Fahrenheit to indicate that raising the vaccine to this temperature once for up to 12 hours has no effect on the product is added to Section 16.2 (Storage and Handling) of the package insert.
- A statement advising to protect the product from light by keeping it in the outer carton is added to Section 16.2 (Storage and Handling) of the package insert..
- All sections of Section 17 (PATIENT COUNSELING INFORMATION) of the package insert are changed from passive to active voice based on FDA guidance.
- Age range, “For 2 - 49 years of age” is added to the Outer Carton.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. 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 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 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 include these changes.
We will include the information contained in the above referenced supplement in your Biologics License Application file.
Wellington Sun, M.D.
Division of Vaccine and Related
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling