October 2, 2009
Our STN: BL 125127/292
Attention: Ms. Judith A. Magner
Associate Director, Vaccines
U.S. Regulatory Affairs
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Ms. Magner:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, to include data from the confirmatory clinical studies to verify and describe the clinical benefit.
We licensed Influenza Virus Vaccine under the accelerated approval regulations. Approval of this supplement fulfills your accelerated approval commitments (21 CFR 601.41) to conduct a comparative safety and immunogenicity study of Fluarix and Fluzone in adults 18 years of age and older and to conduct a placebo-controlled clinical endpoint efficacy study of Fluarix in subjects 18-64 years of age as stated in commitments numbered 1 and 2 of the August 31, 2005, approval letter.
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
We acknowledge that you have agreed to establish a pregnancy registry to prospectively collect data on spontaneously-reported exposures to Fluarix during pregnancy. A protocol for this pregnancy registry will be submitted by June 30, 2010. This protocol will address elements found in FDA’s guidance for Industry on Establishing Pregnancy Exposure Registries (9/2/2002) (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM071639.pdf). The pregnancy registry will be established by June 30, 2011.
Please submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 125127. We may request a supplement if we think labeling changes are needed.
Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
- Postmarketing Study Protocol
- Postmarketing Study Final Report
- Postmarketing Study Correspondence
- Annual Report on Postmarketing Studies
For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. The status report for each study should include:
- information to identify and describe the postmarketing commitment,
- the original schedule for the commitment,
- the status of the commitment (i.e. pending, ongoing, delayed, terminated, or submitted), and
- an explanation of the status including, for clinical studies, the patient accrual rate (i.e. number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Internet site (http://www.fda.gov/cder/pmc/default.htm). For further information, please refer to the April 2001 Draft Guidance for Industry: Reports on the Status of Postmarketing Studies – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/cber/gdlns/post040401.htm).
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 (ten for circulars and five for other labels). 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.
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.
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling