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March 18, 2010 Approval Letter - Kogenate FS

March 18, 2010

Our STN: BL 103332/6088                      

Bayer HealthCare LLC
Attention: Robert W. Kozak, Ph.D.
800 Dwight Way, P.O. Box 1986
Berkeley, CA  94701-1986

Dear Dr. Kozak:

We have approved your request to supplement your biologics license application for Antihemophilic Factor (Recombinant), to request an increase of non-refrigerated storage temperature from 25°C to 30°C for up to 3 months within the 30-month refrigerated expiry period, for the final drug product and the accompanying diluent of Antihemophilic Factor (Recombinant) at dosage strengths of 250, 500, 1000, 2000, and 3000 IU.

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. Provide a PDF electronic copy as well as three original paper copies for all labels.

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 or substantial clinical experience to support such claims [21 CFR 202.1(e)(6)].

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