From: Pracht, Leigh
Sent: Wednesday, November 07, 2012 3:44 PM
To: 'CDCA (Cindy Cao)'
Subject: RE: Information request re: STN 125466/0 
Cindy,

As a clarification of this request, please provide a new CE referencing 21 CFR Part 25.31(c), and justifying why is that applicable to your BLA.
21 CFR Part 25.31(c) does not require "Expected Introduction Concentration (EIC)" that is discussed in the currently submitted BLA.  Overall, it is best to send a new request (Title page, TOC, Text).

Thank you,

Leigh A. Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM 572N; HFM-380
1401 Rockville Pike 
Rockville, MD 20852 
Telephone: 301-827-6116
Fax: 301- 827-2857 
Leigh.Pracht@fda.hhs.gov

_____________________________________________
Information request Email, November 7, 2012 - Novoeight

From: Pracht, Leigh 
Sent: Wednesday, November 07, 2012 2:47 PM
To: CDCA (Cindy Cao)
Subject: Information request re: STN 125466/0


Our Reference:  BL 125466/0

Novo Nordisk Inc.
Attention:  Cindy Cao, PhD
November 7, 2012
Sent by email

Dear Dr. Cao:

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. Your request for Categorical Exclusion (CE) to omit preparation of an Environmental Assessment, under 21 CFR Part 25.31(b) as part of the original BLA STN 125466/0 for NovoEight (Antihemophilic Factor (Recombinant), Plasma/Albumin Free) is not applicable to a marketing application of a biologic product.  Please submit the applicable exclusion for your product - 21 CFR Part 25.31(c) as soon as possible.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.

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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