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August 30, 2010 Clarification Letter - Afluria

Our STN: BL 125254/132

CSL Limited
Attention: Paul Hartmann, R.Ph.
1020 First Avenue
P.O. Box 61501
King of Prussia, PA  19406-0901

Dear Mr. Hartmann:

The purpose of this letter is to clarify your pediatric study fulfillment requirements that were omitted from our approval letter, dated November 10, 2009.

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.

We are waiving the pediatric study requirement for ages birth to < 6 months of age because Afluria® does not represent a meaningful therapeutic benefit over initiating vaccination at 6 months of age and Afluria is not likely to be used in a substantial number of pediatric patients < 6 months of age.

We note that study CSLCT-FLA-04-05 under this submission has fulfilled the pediatric study requirement for ages 6 months through 16 years for this application.

You are no longer required to conduct the following postmarketing studies under STN 125254/0, and thus are released from these requirements:

  1. CSL Limited agrees to conduct Study No. CSLCT-USF-06-29, an uncontrolled, open-label, safety and tolerability study of CSL Limited's Afluria in a pediatric population ages 6 months to less than 18 years.
  2. CSL Limited agrees to conduct Study No. CSLCT-USF-07-36, a non-inferiority immunogenicity and safety study with CSL Limited's Afluria and a U.S. Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a pediatric population from 6 months to less than 18 years of age.

We acknowledge your April 20, 2010 commitment to submit a supplement to this biologics license application by November 30, 2010, to include the results of the following studies:

  1. CSLCT-USF-06-29, an uncontrolled, open-label, safety and tolerability study of CSL Limited's Afluria in a pediatric population ages 6 months to less than 18 years.
  2. CSLCT-USF-07-36, a non-inferiority immunogenicity and safety study with CSL Limited's Afluria and a U.S. Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a pediatric population from 6 months to less than 18 years of age.

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

Sincerely yours,

/signature/

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research