Our STN: BL 125063/822
Baxter Healthcare Corporation
Attention: 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 for the new indication for routine prophylaxis to prevent or reduce frequency of bleeding episodes in adults and children with Hemophilia A.
The review of this product was associated with the following National Clinical Trial (NCT) number(s): NCTT00157053, NCT00157105, NCT00157040, NCT00157157, and NCT002243386.
Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of 10-point font.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h [OPTION: and FDA Form 2567 as appropriate].
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.
You may submit two 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, Rockville, MD 20852-1448. You must submit 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)).
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)).
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We note that you have fulfilled the pediatric study requirement for all relevant pediatric age groups for this application.
This product is appropriately labeled for use in ages 0-16 years for this indication. Therefore, no additional studies are needed in this pediatric group.
We note that you have agreed to continue routine monitoring and reporting of adverse events, including submitting 15-day expedited reports for serious adverse events and Periodic Safety Update Reports (PSURs). PSURs will be submitted semiannually for the first three years after approval for the new indication and then annually thereafter.
We will include information contained in the above-referenced supplement in your biologics license application file.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research