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September 25, 2013 Approval Letter - Hizentra
Our STN: BL 125350/316
CSL Behring AG
Attention: Paula Hines, PhD
CSL Behring LLC
1020 First Avenue
PO Box 61501
King of Prussia, PA 19406-0901
Dear Dr. Hines:
We have approved your request to supplement your biologics license application for Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra), for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older for biweekly (every two weeks) administration.
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.
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 [this/these] change(s).
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 are waiving the pediatric study requirement for the pediatric population of 0 to 2 years of age because necessary studies are impossible or highly impracticable, due to the rarity of primary immunodeficiency diagnosed in this age group.
This product is appropriately labeled for use in the pediatric population of 2 to 16 years of age for the biweekly dosing regimen for this indication. Therefore, no additional studies are needed in this pediatric group.
We will include information contained in the above-referenced supplement in your biologics license application file.
Basil Golding, MD
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research