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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

January 5, 2007 Approval Letter - Influenza Virus Vaccine Live, Intranasal

OUR STN: BL 125020/90

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 Virus Vaccine Live, Intranasal, to convert from the frozen formulation to a liquid formulation.

The dating period for FluMistĀ® vaccine shall be 18 weeks from the date of manufacture of the final filled container, but not beyond June 30th of the given influenza season. The recommended storage condition for the product will be 2o to 8o C. The date of manufacture shall be defined as the start date of filling into final containers. Any extension of the dating period will require the submission and approval of supportive data as a prior approval supplement to your BLA.

Under the Pediatric Research Equity Act (PREA), all applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are deferring pediatric studies for FluMistĀ® studies as outlined in your submission to BLA Supplement STN 125020/225 dated April 27, 2006. This proposal will be addressed in detail at the time of an action taken on BLA Supplement 125020/322, submitted May 1, 2006, which is currently under review.

We acknowledge your written commitments as described in your letter dated December 22, 2006, as outlined below:

Postmarketing Study subject to reporting requirements of 21 CFR 601.70:

 

  1. You have committed to propose and conduct further clinical studies to characterize the biodistribution of the CAIV-T formulation. A timeline of the submission of the proposal and completion of the studies will be provided, following consultation with CBER on study design, after approval.

 

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70:

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Please submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA STN 125020.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies. In addition, you may wish to submit 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, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

We have considered your proposed proprietary names ------------------------------------- and ------------------, in consultation with CBER's Advertising and Promotional Labeling Branch, and conclude that under 21 CFR Part 201 the proposed proprietary names -----------------------------and ------------------- are both unacceptable. You have agreed to retain the name FluMistĀ® for the liquid formulation.

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 to support that claim.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

Paul G. Richman, Ph.D.
Acting 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

 


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