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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 25, 2010 Approval Letter - Alphanate

Our STN: BL 102475/5274

Grifols Biologicals Inc.
Attention: Mr. Frank Marte
5555 Valley Boulevard
Los Angeles, CA 90032-3548

Dear Mr. Marte:

We have approved your request to supplement your biologics license application for Antihemophilic Factor/von Willebrand Factor Complex (Human) [Alphanate] to include:

  • Use of the new Mix2Vial® Reconstitution System manufactured by Medimop, and associated labeling changes.
  • Statements regarding the capacity of the Alphanate manufacturing process to reduce infectivity of an experimental agent of transmissible spongiform encephalopathy.
  • Revisions to sections of the Prescribing Information, including the deletion of the use of Alphanate for control and prevention of bleeding in patients with Acquired Hemophilia due to lack of data to support this indication.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies in triplicate.

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 acknowledge your written commitments as described in your letter of August 30, 2010 as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70

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The final report will be submitted as a PMC Submission - Final Study Report to the following address:

John A. Eltermann, Jr., R.Ph., M.S.
Division of Manufacturing and Product Quality
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Food and Drug Administration
Suite 200N, HFM-670
1401 Rockville Pike
Rockville, MD 20852-1448

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/signature/

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