January 21, 2010 Approval Letter - Recombinate
Our STN: BL 103375/5304
Baxter Healthcare Corporation
Attention: Mr. Douglas Hunt
One Baxter Way
Westlake Village, CA 91362
Dear Mr. Hunt:
We have approved your request to supplement your biologics license application for Antihemophilic Factor (Recombinant) to allow revisions to the package insert to include updated post-marketing safety information.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide content of labeling in Structured Product Labeling format.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research