Information Request, January 16, 2013 - Novoeight



From:                    Pracht, Leigh

Sent:                    Wednesday, January 16, 2013 8:14 AM

To:                      Pracht, Leigh

Subject:                 FW: Information Request BLA 125466/0

 

Our Reference: BL 125466/0

Novo Nordisk Inc.

Attention: Cindy Cao, PhD

January 16, 2013

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.     For the DS please provide the complete validation / qualification reports for the -----------------------------(b)(4)-------------------------- tests.

 

2.   For the DP please provide the complete validation / qualification reports for the Bacterial Endotoxin and Sterility tests.

 

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 March 15, 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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