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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memorandum, July 8, 2011 - Anascorp

 

Our STN:  125335/0
Rare Disease Therapeutics, Inc.
Attention:  Ms. Jennifer Spinella
July 8, 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 request for postmarketing commitments (PMCs), as a condition of the approval:
 
1) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
 
2) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

 
---------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------.
 
3) ---------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------.
 
---------------------------------------------------------------------(b)(4)--------------------------------------------------------------------.
 
4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------.
 
 
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 agreement/proposed revisions to these PMCs as an amendment to this application by July 13, 2011. If you are unable to respond by this date, please contact me immediately to identify an alternate date. You may submit this amendment as an attachment to an email, provided the amendment is complete.
 
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