May 26, 2011 Approval Letter - FluMist
Our STN: BL 125020/1465
Attention: 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®) with revisions to the package insert to include data from clinical trials characterizing vaccine virus shedding in healthy subjects and from small studies of immunocompromised subjects after administration of FluMist (sections 14.4 and 14.5, respectively). The language agreed upon was modified from that you originally proposed. Specific changes include presentation of relevant information about vaccine virus shedding in table format.
The review of this product was associated with the following National Clinical Trial (NCT) number(s): 00091702, 00192140, 00112112, and 00344305.
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 and FDA Form 2567 as appropriate.
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 information contained in the above-referenced supplement in your biologics license application file.
Division of Vaccines and Related
Office of Vaccines Research and Review
Center for Biologics
Evaluation and Research