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Vaccines, Blood & Biologics
Our STN: 125335/0
Rare Disease Therapeutics, Inc.
Attention: Ms. Jennifer Spinella
July 11, 2011
Dear Ms. Spinella:
We are reviewing your resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab’)2, (Equine), Injection. We are providing the following comment/request for revision:
Your proposed specification for protein of --------(b)(4)------ is not supported by your validation data. Your original specification calls for -(b)(4)- protein/vial, and you validated a fill size of ----(b)(4)----.This would suggest a maximum protein content of 120 mg/vial, assuming a maximum fill size of (b)(4) and a protein concentration of your bulk solution at (b)(4).Please revise the protein specification to reflect the validated fill size and current protein specification.
Please submit a table of revised specifications to include the change described above, as well as expressing sulfate and cresol as mg/vial. Assuming a (b)(4) maximum fill, this should equate to 1.7 mg/vial sulfate and 0.41 mg/vial cresol.
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 response to this request as an amendment, sent as an email attachment, no later than July 18, 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.
Regulatory Project Manager