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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, July 6, 2011 - Anascorp

Our STN:  125335/0

Rare Disease Therapeutics, Inc.
Attention:  Ms. Jennifer Spinella
July 6, 2011
By email
 
Dear Ms. Spinella:
 
We are reviewing your resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab’)2 Intravenous (Equine).  We are providing the following comment:
 
Since the fill volume and reconstitution volume of your product are not identical, expressing the protein, sulfate, and cresol content of the final lyophilized product as a percentage may be misleading. To address this concern, as well as to maintain consistency with your glycine, sodium chloride, borate, and sucrose content unitage, please express protein, sulfate, and cresol values as "mg/vial". 
 
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 August 3, 2011.
 
If you have any questions, please contact me at (301)827-6157.
 
Sincerely,
 
 
 
Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR