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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 18, 2010 Approval Letter - Recombinate

March 18, 2010

Our STN: BL 125063/671 
Baxter Healthcare Corporation
Attention: Ms. Arwa Shurrab
One Baxter Way
Westlake Village, CA  91362

Dear Ms. Shurrab:

We have approved your request to supplement your biologics license application for Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method, to revise the package insert to include additional adverse events seen in postmarketing pharmacovigilance monitoring.

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.  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.

Sincerely yours,

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