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December 2, 2011 Approval Letter - Afluria
Our STN: BL 125254/259
December 2, 2011
Attention: Paul R. Hartmann, R.Ph.
1020 First Avenue
P.O. Box 60446
King of Prussia, PA 17406-0446
Dear Mr. Hartmann:
We have approved your request to supplement your biologics license application (BLA) for Influenza Virus Vaccine, to include data from confirmatory clinical studies to verify and describe the clinical benefit and to include additional data describing use in children.
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 placebo-controlled clinical endpoint efficacy and safety study in healthy adults 18 to less than 65 years of age and a non-inferiority immunogenicity and safety study in an at risk adult population as stated in commitments numbered 1 and 2 of the September 28, 2007, approval letter.
In addition this study fulfills your commitments to conduct a study to evaluate the safety and immunogenicity of Afluria in children 6 months through 18 years of age as stated in commitment numbers 1 and 2 of the August 30, 2010, approval letter.
The review of this product was associated with the following National Clinical Trial numbers: NCT00562484, NCT00735475, NCT00959049 and NCT00562484.
Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert or, alternatively, accompany the prescription drug labeling. We request that the text of information distributed to patients be printed in a minimum of 10-point font.
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/
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.
AGREED UPON POSTMARKETING COMMITMENTS
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
We acknowledge your written commitment as described in your amendment of November 14, 2011 that you have agreed to:
- Establish a pregnancy registry to prospectively collect data on spontaneously-reported exposures to Afluria during pregnancy.
A protocol for this pregnancy registry will be submitted by June 30, 2012. This protocol will address elements found in FDA’s 9/2/2002 guidance for Industry on Establishing Pregnancy Exposure Registries (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM071639.pdf). The pregnancy registry will be established by June 30, 2013.
Please submit clinical protocols to your IND, with a cross-reference letter to this supplement STN BL 125254/259. We may request a supplement if we decide that 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. Label your annual report an “Annual Status Report of Postmarketing Study Commitments.” 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 Web site (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm). Please refer to the February 2006 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/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM080569.pdf) for further information.
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