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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CRMTS 6909 Cover Letter - Wilate, December 23, 2008

Our Reference: CRMTS #6909, STN 125251/0/29

 

Octapharma Pharmazeutika

Attention:  Mr. Stanley Ammons

c/o U.S. Associate for Octapharma

121 River Street, 12th floor

Hoboken, NJ 07030

Dear Mr. Ammons:

We have reviewed your submissions under STN 125251/0/29, CRMTS #6909, for von Willebrand Factor/Factor VIII Concentrate (Human) (VWF:RCo) [WILATE], to seek agreement with FDA on the proposal for the use of a modified analytical method to measure the relevant concentrations of VWF:RCo in plasma after WILATE infusion, and for potency estimations of VWF-containing concentrates.  The proposal relates to items #1 and #31 of the Complete Response letter dated January 8, 2008.  You also sought concurrence from FDA to resume previous advanced discussions on the acceptability of Octapharma's European efficacy data for the licensure of WILATE in the United States.

FDA sent a fax on December 8, 2008, responding to the questions posed in your meeting package.  Octapharma notified FDA on December 10, 2008 that after reviewing the responses you wish to cancel the face-to-face meeting with FDA scheduled for December. 12, 2008 from 9:30 a.m. to 11:00 a.m.

In lieu of the meeting, enclosed is a copy of the December 10, 2008 fax, which will serve as the Official Meeting minutes.

If you have any questions, please contact Pauline Cottrell of this office at (301) 827-6162.

Sincerely yours,

 

Basil Golding M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
   Evaluation and Research