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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Meeting Summary Status - Wilate, November 3, 2009

Meeting DATE:3-Nov-2009

FROM: Pauline Cottrell, DBA, HFM380    

RE: Meeting Summary Status of STN125251/0

Attendees: Pauline Cottrell, Timothy Lee, Hon Sum Ko, Iftekhar Mahmood, Basil Golding

SPONSOR: Octapharma Pharmazeutik Produktionsges.m.b.H.

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

Due date: 4-Dec-09

To:     File

 

Bacground

Meeting was held to discuss status of review and if the BLA will be approved. Concerns about potency assay were still to be resolved. Indication for use was still not clear, -------------------(b)(4)---------------------.  Labeling changes were still under review.

 

Summary:

It was determined that the PK data is acceptable for approval.

 

----------------------------------------------(b)(4)------------------------------------------           --------------------------------------------------------------

 

Dr. Lee said that if Octapharma uses either the manual method or automated BCS method for potency testing, approval will be granted.

 

Action Items:

Call Octapharma of ask that they use either the BCS method or manual method for potency assay.