Biologics License Application Filing Letter - BAT
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Our STN: BL 125462/0
Attention: Mr. Terry Kraynyk
155 Innovation Drive
Winnipeg, Manitoba R3T 5Y3
Dear Mr. Kraynyk:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated September 20, 2012 for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine) to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is March 22, 2013. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than February 20, 2013. If post marketing study commitments (506B) are required, we will contact you no later than February 20, 2013.
At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
If you have any questions, please contact the Regulatory Project Manager, Nannette Cagungun, at (301) 827-6174.
Iliana Valencia, M.S.
Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research