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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, June 29, 2011 - Anascorp

Our STN:  125335/0

Rare Disease Therapeutics, Inc.
Attention:  Ms. Jennifer Spinella
June 29, 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 comments:
 
1.      We have performed a preliminary review of your carton and container labels, and find your draft labels (in particular the container) do not comply with the 21 CFR 610.60, 610.61, 610.62, 610.63, and 610.64. 
 
2.      We have revised the proper name of this product to be, Centruroides (Scorpion) Immune F(ab’)2, Injection(Equine). While this may again be changed, please use this proper name in your revised labeling.
 
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 revised labels, in electronic format, as an amendment to this file no later than July 5, 2011.. 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.
 
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. 
 
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