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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information request Email, August 15, 2013 - Novoeight

 

From:   Pracht, Leigh
Sent:    Thursday, August 15, 2013 11:14 AM
To:       'LEWP (Lewis Pollack)'
Subject:           STN 125466/0 Information request 08152013
Attachments:   STN125466_draft-pi-text.doc
 
Importance:     High
 
Our Reference: BL 125466/0
 
Novo Nordisk Inc.
Attention: Lewis Pollack, PhD
August 15, 2013
Sent by email
 
Dear Dr. Pollack:
 
We are reviewing your October 15, 2012 biologics license application (BLA) for Antihemophilic
Factor (Recombinant) [NOVOEIGHT]. We are providing the following comments and request
for additional information to continue our review:
 
1.         We have reviewed the package insert and request changes be made in accordance with
the attached MS Word document.
 
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 by August 23,
2013 referencing the date of this request. Please include both a red-line strike out and clean copy
of the revised package insert in WORD format. 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 October 16, 2013.
 
If you have any questions, please contact me at (301) 827-6116.
 
Best regards,
 
Leigh A. Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM562N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116
Fax: 301- 827-2857
Leigh.Pracht@fda.hhs.gov
 
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