
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:

 

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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