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
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.