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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

October 5, 2006 Approval Letter - FluLaval

Our STN: BL 125163/0

ID Biomedical Corporation of Maryland
Attn: Jane L. Halpern, Ph.D.
Director, Regulatory Affairs
6996 Columbia Gateway Drive, Suite 103
Columbia , MD 21046-3303

Dear Dr. Halpern:

We are issuing Department of Health and Human Services U.S. License No. 1739 to ID Biomedical Corporation of Quebec (IDB), Sainte-Foy, Canada, under the provisions of section 351(a) of the Public Health Service Act controlling the sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.

Under this license, you are authorized to manufacture Influenza Virus Vaccine. You may label your Influenza Virus Vaccine with the proprietary name FluLaval™. FluLaval™ is indicated for active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. This indication is based on immune response elicited by FluLaval™, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FluLaval™. FluLaval™ is not indicated for use in children.

Under this license, you are authorized to manufacture FluLaval™ at your ---------------, and ------------------------------------- locations. Virus propagation and allantoic fluid inactivation will be performed in --------------------. Monovalent bulk production, formulation of the trivalent final product, filling, labeling, and packaging will be performed in ------------------------. The vaccine will be marketed in a 5 mL vial containing ten 0.5 mL doses.

The dating period for FluLaval™ shall be 12 months from the date of manufacture of the formulated vaccine bulk when stored at 2-8°C, but not beyond June 30th of the given influenza season. The date of manufacture is defined as the date on which the trivalent bulk vaccine is formulated. Potency testing performed on the trivalent bulk must commence within -- days after formulation. Any extension of the dating period will require the submission and approval of supportive data as a prior approval supplement to your BLA.

Please submit the first 5 monovalent concentrates of each strain for testing, along with the protocol for each submitted lot. All final trivalent bulk samples should be submitted together with lot release protocols in the proper format showing results of applicable tests. You shall not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).

You must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of FluLaval™ , or in the manufacturing facilities.

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 have reviewed your submission dated September 14, 2006, and agree that a deferral of your pediatric studies for FluLaval™ in children less than 18 years of age is justified as you are pursuing with due diligence a pediatric indication with either a thimerosal-reduced or a thimerosal-free formulation of FluLaval™.

Postmarketing Studies subject to reporting requirements of 21 CFR 601.70

Products approved under the accelerated approval regulations, 21 CFR 601.41, require further adequate and well-controlled confirmatory clinical studies to verify and describe clinical benefit. We remind you of your postmarketing study commitments specified in your submissions dated September 21, 25, and 27, 2006. These commitments, along with any completion dates agreed upon, are listed below.

  1. To conduct Study IDB 707-108, a comparative safety and immunogenicity study of FluLaval™ and Fluzone ® in adults 50 years of age and older. The study was initiated in October 2005. The final study report will be submitted by November 30, 2006.
  2. To conduct Study IDB 707-106, a placebo-controlled clinical endpoint study of FluLaval™ in subjects 18-49 years of age. This two year study was initiated in September 2005. The final study report will be submitted by December 31, 2007.

We request that you submit future clinical protocols and clinical study-related documentation to your IND --------; please provide a cross-reference letter to this BLA.

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70

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Please submit non-clinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA, STN BL 125163. 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 Web site (http://www.fda.gov/cder/pmc). 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) for further information.

Please submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and distribution reports as described in (21 CFR 600.81). Under 21 CFR 600.80(c)(2) [Periodic Adverse Experience Reports], you must report each adverse experience not reported under paragraph (c)(1)(i) of this section at quarterly intervals for the first 3 years following approval, and then at annual intervals. Since your product is characterized as a vaccine, you must also submit these reports to the Vaccine Adverse Event Reporting System (VAERS) using the pre-addressed form VAERS-1.

You must submit reports of biological product deviations under 21 CFR 600.14. You should promptly identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as one original paper copy.

Please note that the accelerated approval regulation concerning promotional materials (21 CFR 601.45) stipulates that all advertising and promotional labeling items that IDB wishes to distribute in the first 120 days following approval, must have been received by FDA prior to the approval date. After approval, promotional items intended for dissemination after the first 120 days following approval should be submitted to the FDA 30 days prior to the anticipated distribution date. Please submit these materials with 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. Two copies of all final advertising and promotional labeling materials should be submitted at the time of initial dissemination, accompanied by 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 submitted data to support such claims to us and received CBER approval for such claims.

If you have any questions, please contact Dr. Sara Gagneten at 301-827-3070.

Sincerely yours,

Mary A. Malarkey
Director
Office of Compliance
      and Biologics Quality
Center for Biologics
      Evaluation and Research
Norman W. Baylor, Ph.D.
Director
Office of Vaccines
      Research and Review
Center for Biologics
      Evaluation and Research

 


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