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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Letter, July 24, 2013 - Novoeight

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our Reference:  BL125466/0
 
Novo Nordisk Inc.
Attention: Lewis Pollack, PhD
July 24, 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:
 
As discussed at the Late Cycle meeting for STN 125466/0 on 11 July 2013, please find below information related to a ----------(b)(4)------------- method that our lab has developed and found suitable for the purpose of assessing contents of ----------------------------(b)(4)-------------------------------------:
 
(b)(4) Procedure
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
 
Sample Preparation
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------.
 
Results
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
 
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. The results from SRM and control met all assay validity criteria and that from the three lots of products are within the specifications for -(b)(4)- content and         -----(b)(4)-----, proposed in the BLA. 
 
Conclusion
We find this method to be suitable for the assessment of content and (b)(4) in NovoEight, and hope this information is helpful for your development of a validated procedure for these product quality attributes. Dr. Lokesh Bhattacharyya may be contacted through me should you have questions.
 
If you have any questions, please contact me at (301) 827-6116.
 
Sincerely,
 
Leigh Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB