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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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August 26, 2010 Approval Letter, STN: BL 102476/5218 - Profilnine® SD

Our STN: BL 102476/5218                       

 
Grifols Biologicals Inc.
Attention: Mr. Frank Marte
5555 Valley Boulevard
Los Angeles, CA 90032
 
Dear Mr. Marte:
 
We have approved your request to supplement your biologics license application for Factor IX Complex, to include the change to a new Medimop Mix2Vial Reconstitution System and the revised Package Insert.
 
Please submit all final printed labeling at the time of use and include implementation information on Forms FDA 356h and FDA 2567, as appropriate. Provide content of labeling in Structured Product Labeling format.
 
You must submit two copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 [21 CFR 601.12(f)(4)]. You may submit two draft copies of proposed advertisement and promotional labeling for advisory comment with Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. 
 
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 letters of August 20, 2010 and August 23, 2010 as outlined below:
 
Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.  
 
  1. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 
 
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 Review 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,
 
 
 
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review  
Center for Biologics
 Evaluation and Research