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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Letter, November 28, 2012 - BAT

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our Reference: STN 125462/0
 
Cangene Corporation
Attention: Mr. Terry Kraynyk
November 28, 2012
Sent by email
 
Dear Mr. Kryanyk:

We are reviewing your biologics license application for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine) submitted on September 20, 2012 for Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin (BoNT) serotypes A, B, C, D, E, F or G. We have the following request for information:
 
CMC
 
1. Please submit -----(b)(4)---- reports AB32EU.034090.BSV, AB32EZ.034090.BSV, and AB47CR.034090.BSV.
 
2. Please submit a validation report or a cross-reference to a master file supporting use of the West Nile virus -(b)(4)- test on equine plasma performed at the -------(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 response to this information request as an amendment to this file by December 14, 2012 referencing the date of this request. 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 you have any questions, please contact me at (301) 827-6174.
Sincerely,
Nannette Cagungun, MS, PD, RAC
Regulatory Project Manager
OBRR/CBER/FDA, HFM-380
1401 Rockville Pike Rockville, MD 20852-1448
Tel: (301) 827 6174
Fax: (301) 827 2857