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Resubmission Letter - Wilate, June 24, 2009
Our STN: BL 125251/0
Attention: Mr. Stanley Ammons
121 River Street, 12th floor
Hoboken, NJ 07030
Dear Mr. Ammons:
We received your June 3, 2009, resubmission to your biologics license application for Coagulation Factor VIII/von Willebrand Factor Complex (Human) on June 4, 2009.
The resubmission contains your response to our January 8, 2008 complete response letter.
We consider this a complete, class 2 response to our action letter. Therefore, the user fee goal date is December 4, 2009.
If you have any questions, please contact the Regulatory Project Manager, Pauline Cottrell, at 827-6162.
Jeffrey M. Anderson, M.S., RAC
Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research