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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, July 5, 2011 - Anascorp

Our STN:  125335/0

Rare Disease Therapeutics, Inc.
Attention:  Ms. Jennifer Spinella
July 5, 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 revisions to the content of labeling (package insert), see following pages. You will find both a clean copy of our proposed changes, and a track changes version.
 
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 revision to the content of labeling as an amendment to this file, referencing the date of this request, by July 9, 2011.  Please include a revision date, version number, etc., so that we can clearly identify which version we are reviewing. Please include both a red-line strike out and clean copy of the revised package insert in WORD format. FDA is willing to accept your revised content of labeling as an email attachment, provided the attachment contains all the information that would be submitted in an amendment, i.e., Form FDA 356h, coverletter, etc. 
 
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