October 10, 2008 Approval Letter - Kogenate FS
Our STN: BL 103332/5794
Bayer HealthCare LLC
Attention: Robert Kozak, Ph.D.
800 Dwight Way, P.O. Box 1986
Berkeley , CA 94701
Dear Dr. Kozak:
We have approved your request to supplement your biologics license application for Antihemophilic Factor (Recombinant) (Kogenate FS) to revise the indications for use to include routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage.
Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert. We request that the patient package insert be printed in a minimum of 10-point font.
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. Please provide a PDF-format electronic copy as well as original paper copies (5 for circulars and 3 for other labels)].
In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, 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 submitted data to support such claims to us and had them approved.
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens must contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We note that you have fulfilled the pediatric study requirement for all relevant pediatric age groups for this application.
We will include information contained in the above-referenced supplement in your biologics license application file.
-- signature --
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research