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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 20, 2012 Approval Letter - VARIZIG

 

Our STN: BL 125430/0
 
Cangene Corporation
Attention: Mr. Terry Kraynyk
155 Innovation Drive
Winnipeg, Manitoba R3T 5Y3
Canada
 
Dear Mr. Kraynyk:
 
We have approved your biologics license application for Varicella Zoster Immune Globulin (Human) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Varicella Zoster Immune Globulin (Human), under your existing Department of Health and Human Services U.S. License No. 1201. Varicella Zoster Immune Globulin (Human) is indicated for post-exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella.
 
Under this authorization, you are approved to manufacture Varicella Zoster Immune Globulin (Human) at your facility in Winnipeg, Manitoba, Canada. You may label your product with the proprietary name VARIZIG® and market it in 6 mL sizes.
 
We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.
 
The dating period for Varicella Zoster Immune Globulin (Human) shall be 36 months from the date of manufacture when stored at 2-8 °C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product in accordance with 21 CFR 610.50. Following the final sterile filtration, no reprocessing/reworking is allowed without prior approval from the Agency. The expiration date for the packaged product, VARIZIG plus Sterile Diluent, shall be dependent on the shortest expiration date of any component.
 
You currently are not required to submit samples of future lots of Varicella Zoster Immune Globulin (Human) to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2. We will continue to monitor compliance with 21 CFR 610.1 requiring completion of tests for conformity with standards applicable to each product prior to release of each lot.
 
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of Varicella Zoster Immune Globulin (Human), or in the manufacturing facilities.
 
You must submit reports of biological product deviations under 21 CFR 600.14. You should identify and investigate all manufacturing deviations promptly, including those associated with processing, testing, packing, labeling, storage, holding, and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
 
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)].
 
ADVERSE EVENT REPORTING
 
You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports as described in 21 CFR 600.81. You should submit postmarketing adverse experience reports and distribution reports to the Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology HFM-210, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Prominently identify all adverse experience reports as described in 21 CFR 600.80. 
 
In addition, you must submit adverse event reports for any infectious disease transmission within 15 days after learning of the event. Infectious disease transmission refers to an adverse event that involves suspected or confirmed transmission of an infectious agent, whether the recipient develops the infectious disease or only has serologic or other evidence. If an infectious disease transmission event is serious and unexpected, you must submit a 15-day “alert report,” as required under 21 CFR 600.80 (c)(1)(i). Infectious disease transmission events that do not meet criteria for expedited submission require periodic reports and must be submitted as individual case reports within 15 days, as authorized under 21 CFR 600.80(c)(2)(i). You should submit reports for all other non-expedited adverse events under the periodic reporting requirements specified in 21 CFR 600.80(c)(2).
 
PEDIATRIC REQUIREMENTS
 
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.
 
Because the biological product for this indication has an orphan drug designation, you are exempt from this requirement.
 
AGREED UPON POSTMARKETING COMMITMENTS
 
Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.  
 
We acknowledge your written commitments as described in your letters of December 14 and 17, 2012 as outlined below:
 
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We request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments, and final reports to your BLA, STN BL 125430/0.
 
Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
 
  • Postmarketing Study Correspondence
  • Postmarketing Study Commitment – Final Study Report
  • Supplement Contains Postmarketing Study Commitment – Final Study Report
 
For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.” The status report for each commitment should include:
 
  • The original schedule for the commitment, and
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).
 
When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.
 
Sincerely yours,
 
 
Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research