Resubmission Letter - Wilate, June 24, 2009

Our STN:  BL 125251/0

 

Octapharma Pharmazeutika
Attention:  Mr. Stanley Ammons
Octapharma USA
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.

Sincerely yours,

 

Jeffrey M. Anderson, M.S., RAC
Chief
Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research