DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Our Reference: STN 125462/0
Attention: Mr. Terry Kraynyk
December 31, 2012
Sent by email
Dear Mr. Kraynyk:
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 the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin (BoNT) serotypes A, B, C, D, E, F or G. We determined that the following information is necessary to continue our review:
- The files submitted to BLA 125262 from CDC expanded access program IND 6750 include HHS/ASPR/BARDA semiannual summary reports up to report #3. These HHS/ASPR/BARDA reports cover from 15-Jan-2008 through 31-Dec-2011. However, the information provided is inadequate to evaluate the safety of NP-018 in the target population, particularly in children. Therefore, we request additional clinical safety data available up until the present time. Please provide HHS/ASPR/BARDA report #4 dated 27-July-2012. Also, please provide other data of interest which have occurred between report #3 and the present, including deaths, serious adverse events, severe adverse events, and episodes of anaphylaxis or serum sickness. Please also provide summaries and detailed narratives of all pediatric data to the present, including all pediatric dosing information, with infant data presented both as included and separate collections.
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 January 18, 2013 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 we determine that your response to this information request constitutes a major amendment, we will notify you in writing.
If you have any questions, please contact me at (301) 827-6174.
Nannette Cagungun, MS, PD, RAC
Regulatory Project Manager
1401 Rockville Pike Rockville, MD 20852-1448
Tel: (301) 827 6174
Fax: (301) 827 2857
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