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Biologics license application (BLA) Amendment Letter - Octaplas
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our STN: BL 125416/0
Octapharma Pharmazeutika Produktionsges.m.b.H.
Attention: Mr. Stanley Ammons
Octapharma USA, Inc.
121 River Street, 12th floor
Hoboken, NJ 07030
Dear Mr. Ammons:
We received your August 13, 2012 amendment to your biologics license application (BLA), submitted under section 351 of the Public Health Service Act (42 U.S.C. 262), for Pooled Plasma (Human), Solvent/Detergent Treated, on August 13, 2012.
We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Safety and Innovation Act of 2012 and will add an additional three months to the time by which we should complete our review.
Therefore, the action due date is January 21, 2013.
If you have any questions, please contact the Regulatory Project Manager, Pratibha Rana, at (301) 827-6124.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research