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Record of Telephone Conversation - Wilate, November 3, 2009

RECORD OF TELEPHONE CONVERSATION(System Info - 109821 COTTRELL 
PAULINE 11/04/2009 06:46:01 COTTRELL)

Submission Type:    BLA    Submission ID:  125251/0        Office:  OBRR

Product: Coagulation Factor VIII/von Willebrand Factor Complex (Human) 

Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H.                  

Telecon Date/Time:  03-Nov-2009, 03:40 PM            Initiated by FDA? Yes

Telephone Number:                 1-201-604-1123                                                           

Communication Category:      1. Advice

 Author:                                    Pauline Cottrell                             

 Brief Description:                   Potency Assay method for labeling of product

FDA Participants:                   Pauline Cottrell and Timothy Lee        

Non-FDA Participant(s):        Stanley Ammons   

                             

Telecon Body:

Dr. Lee and I called Mr. Stanley Ammons to inform him that the FDA is recommending Octapharma to use either the manual assay or the original BCS assay to determine the potency of Coagulation Factor VIII/von Willebrand Factor Complex (Human).  Dr. Lee explained that the FDA still has unresolved issues with Octapharma’s modified BCS assay.  In addition, the modified BCS assay is not used in most laboratories outside of Octapharma so they would not be able to reproduce the potency value on the label of this product.  Dr. Lee said that if Octapharma can accept FDA’s recommendation to use either the manual method or the original BCS method to assign potency to their product, then the FDA can move forward.

Dr. Lee also asked Mr. Ammons to find out what assay is used to assign potency to this product distributed in other countries where it is approved, such as Germany and Canada.

Mr. Ammons said he would relay the information to his team and let the FDA know which method they will use for the US product.