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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Labeling Review Memo, April 18, 2013 - Kcentra

Date:                April 18, 2013

From:              Kristine T. Khuc, Pharm.D.
                      Consumer Safety Officer
                      Advertising and Promotional Labeling Branch (APLB) (HFM-602)
                      Division of Case Management

Through:         Lisa L. Stockbridge, Ph.D.
                       Branch Chief
                       Advertising and Promotional Labeling Branch (APLB) (HFM-602)
                        Division of Case Management

To:                   Beth Walton, RPM, CBER/OBRR/DBA/(HFM-380)
                        Leland Ross Pierce, M.D., Ph.D., CBER/OBRR/DH/CRB (HFM-392)

Subject:           Labeling Review
                        KCENTRA (Prothrombin complex concentrate (Human))
                        BLA 125421/0
                        Sponsor: CSL Behring
______________________________________________________________________

Background:  The sponsor submitted:
          X           New Approval
                        Changes Being Effected (CBE) supplement
         _____       Prior Approval Supplement (PAS) Amendment
                        Major Amendment

Submission contains:

         X             Prescribing Information (PI)
                        Patient Package Insert (PPI)
                        Carton and/or container labels
                        Other

Resubmission date: April 15, 2013
Action due date: April 29, 2013


APLB Comments/Recommendations

APLB has reviewed the proposed (April 15, 2013) PI and provides the following comments and recommendations to OBRR from a promotional and comprehension perspective.  Additionally, please see the track changes in the attached proposed PI.

General Comments

  • Please ensure that the preferred presentation for cross references in the boxed warning is used (i.e., the numerical identifier in parentheses). 
  • Use bold type sparingly.  Use another format for emphasis, such as italics or underline. 
  • In the Warning and Precautions section of the Highlights, consider combining related information under a subsection into one bullet.
  • Avoid using the vague phrase, “use with caution.”
  • It is unnecessary to provide lengthy descriptions of terms in the footnote of a table.  The lengthy descriptions distract the reader from the main information presented in the table.
  • Avoid using the terms “primary” or “co-primary” endpoints. 
  • Delete the term “rapid” throughout the entire PI. This term is highly promotional, especially when not qualified or quantified.

The above comments have been provided to OBRR as a labeling consult.  If you have any questions regarding this review please contact Kristine T. Khuc, Consumer Safety Officer, at 301-827-6332.