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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 22, 2013 - Novoeight

 

From:                    Pracht, Leigh
Sent:                      Monday, April 22, 2013 11:05 AM
To:                         'lewp@novonordisk.com'
Subject:                 STN 125466/0   Information Request
Our Reference: BL 125466/0
Novo Nordisk Inc.
Attention: Lewis Pollack, PhD
April 22, 2013
Sent by email
 
Dear Dr. Pollack:
 
We are reviewing your October 15, 2012 biologics license application (BLA) for Antihemophilic Factor (Recombinant), Plasma/Albumin Free [NovoEight]. We determined that the following information is necessary to continue our review:
 
1.     Please ship additional NovoEight material, as specified below, to complete the in-support testing.
 
--(b)(4)---         250 IU/vial       two (2) vials
--(b)(4)---         250 IU/vial       five (5) vials
--(b)(4)---         1000 IU/vial     two (2) vials
--(b)(4)---         2000 IU/vial     three (3) vials
--(b)(4)---         3000 IU/vial     three (3) vials
 
Please ship the material to the address below:
 
Karen Campbell
Regulatory Coordinator
Division of Biological Standards and Quality Control (DBSQC)
OCBQ/CBER/FDA HFM-680
NLRC, Bldg. B, Rm. 2410
5516 Nicholson Lane, Kensington, MD 20895
Office (301)594-6255
 
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 May 10, 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 October 15, 2013.
 
If you have any questions, please contact me at (301) 827-6116.
 
Sincerely,
 
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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