
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.
