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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 3, 2013 - Kcentra

From:                                        Thompson, Edward
Sent:                                         Wednesday, April 03, 2013 10:55 PM
To:                                             'David.Desris@cslbehring.com'
Cc:                                             Pierce, Leland Ross; Walton, Beth; Miller, Alisha (Alisha.Miller@fda.hhs.gov)
Subject:                                    Information Request for BL 125421/0

Contacts:                                  David Desris - CSL Behring LLC

Dear Dr. Desris:

 

We are reviewing your March 30, 2012 biologics license application (BLA) for Prothrombin Complex Concentrate (Human).  We determined that the following information is necessary to continue our review:

  1. Please clarify whether investigators dosed Kcentra in RCTs BE1116_3002 and BE1116_3003 using actual potency as stated on the product vials or using nominal potency of 500 IU/vial (25 IU/mL).

 

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. 

Please submit your response to this information request as an amendment to this file by April 4, 2013 referencing the date of this request.  If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.

The action due date for this file is April 29, 2013.

If you have any questions, please contact me at (301) 827-9167.

Sincerely,

 

Edward Thompson
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB

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