
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