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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, March 4, 2011 - Anascorp

From:                     Cordaro, Debbie

Sent:                      Friday, March 04, 2011 11:38 AM
To:                         'Jennifer Spinella'
Subject:                 Information Request for STN 125335/0
Our Reference: BL 125335/0
 
Rare Disease Therapeutics, Inc
Attention: Ms. Jennifer Spinella
Sent by email
 
Dear Ms. Spinella:
 
We are reviewing your biologics license application for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine). We determined that the following information is necessary to continue our review:
 
1. In response to our information request of February 9, 2011 you provided pdf files of data summary tables. The ISS results are based on patient level data/raw data and need to be verified. Please submit patient data listings in the form of SAS transport files for the ISS.
 
2. Additional patient data has been provided to this file which was not reflected in the original package insert submitted. Please include both a red-line strike out and clean copy of the revised package insert in WORD format.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. 
 
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. Please submit your response to this information request as an amendment to this file by March 18, 2011 referencing the date of this request.
 
The action due date for this file is August 3, 2011.
 
If you have any questions, please contact me at (301) 827-6157.
 
Sincerely,
 
 
 
[RPM]
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
 
 
Debbie Cordaro
 
Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
1401 Rockville Pike
Rockville, MD 20852
debbie.cordaro@fda.hhs.gov
Voice: 301-827-6157 Fax 301-827-2857
debbie.cordaro@fda.hhs.gov