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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

November 10, 2009 Approval Letter - Influenza A (H1N1) 2009 Monovalent (ID Biomedical)

Our STN:  BL 125163/135

ID Biomedical Corporation of Quebec
Attention: Mary Beth Ebert, M.S.
2301 Renaissance Blvd.
King of Prussia, PA  19406

Dear Mrs. Ebert:

We have approved your request to supplement your biologics license application (BLA) for Influenza Virus Vaccine, to include the Influenza A (H1N1) 2009 Monovalent Vaccine.

We acknowledge your commitment in your amendment dated November 6, 2009, to submit results from clinical studies using FluLaval-based H1N1 monovalent vaccine in populations for which your seasonal influenza vaccine is currently licensed, as an efficacy supplement to your Influenza Virus Vaccine BLA for FDA review.  This efficacy supplement should contain updated labeling incorporating these clinical data.  You will also include in this supplement ----------------- -----------b(4)--------------------------- ---------------------------- ------------------------------------------ ------------------------------------------ --------------------------------------------- ---------------------------------.  The efficacy supplement should be submitted as soon as possible to the pre-assigned STN 125163/-b(4)- with the descriptor Supplement Contains Postmarketing Study Commitment - Final Study Report.  Please refer to the February 2006 "Guidance for Industry - Reports on the Status of Postmarketing Study Commitments" http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM080569.pdf regarding timing and reporting requirements for postmarketing commitment fulfillment.  Prior to submission of your final study report efficacy supplement, please submit interim clinical data as soon as it is available to your BB-IND--b(4)--.

Please note that your Influenza A (H1N1) 2009 Monovalent Vaccine and labeling approved under this STN 125163/135 may not be distributed until you submit for review and approval a prior approval supplement to your current license for FluLaval to include the use of--b(4)-- as a contract manufacturing organization (CMO), the modification of the release specification changes for the monovalent H1N1 formulation, and the newly introduced ----b(4)---- presentation to be filled at --b(4)--.

Please submit all final printed labeling at the time of use and include completed implementation information on FDA form 356h.  Please provide content of labeling in Structured Product Labeling format.

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

/signature/

Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

 

Attachment: Approved Final Draft Labeling