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February 29, 2012 Approval Letter - T.R.U.E. TEST
Our STN: BL 103738/5074
Mekos Laboratories AS
Attention: Kim M. Sullivan
U.S. Agent for Mekos Laboratories AS
3400 East McDowell Road
Phoenix, AZ 85008
Dear Ms. Sullivan:
We have approved your request to supplement your biologics license application for Thin Layer Rapid Use Epicutaneous Test (T.R.U.E. TEST), to add seven new allergens to the T.R.U.E. TEST.
Under this approval the following new allergens: Gold sodium thiosulfate (GST), Hydrocortisone-17-butyrate (H-17-B), Parthenolide, Methyldibromoglutaronitrile (MDBGN), Bacitracin, 2-Bromo-2-nitropropane-1,3-diol (Bronopol), and Disperse Blue 106 will be added to Panel 3 which will now be designated as Panel 3.2. In addition, Methyldibromoglutaronitrile, (MDBGN) will be added to existing Panel 2.1 (in place of Mercaptobenzothiazole, which is moved to Panel 3.2) which will now be designated Panel 2.2. Although Panel 1.1 is unchanged under this approval, for consistency, the numbering of Panel 1.1 will be changed to Panel 1.2,
The review of this product was associated with the following National Clinical Trial (NCT) numbers: 00640614, 00640250, 00795951, 00133341 and 00612768
The dating period for this product shall be 24 months from the date of manufacture when stored at 2 to 8°C. The date of manufacture for each panel is the date on which the initial specification analysis of the first patch of that panel is performed on the finished product. The expiry date on the carton (containing Panels 1.2, 2.2 and 3.2) shall be the earliest of the expiry dates on the three panels.
Please submit final samples of the product together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).
Your submission addressed postmarketing commitment #1 identified in the June 5, 2007, approval letter for STN 103738/5019 and postmarketing commitment #1 identified in the November 5, 2009, approval letter for STN 103738/5050 for T.R.U.E. TEST. The commitments addressed in this submission are as follows:
#1. To conduct a deferred pediatric study under PREA for the diagnosis of allergic contact dermatitis in pediatric patients ages 12 to 18 for allergens on Panels 1.1, 2.1 and 3.1. As stated in the “Pediatric Requirements” section of this letter, however, this approval is for the use of T.R.U.E. TEST Panels 1.2, 2.2 and 3.2 in adults 18 years of age and older.
#1. To submit an efficacy supplement with a revised package insert and supporting clinical data describing the above Quaternium-15 study by May 2010. The package insert will be submitted in the Physicians Labeling Rule (PLR) format and with Structured Product Labeling (SPL).
We have completed the review of your submission and find that these commitments have been fulfilled.
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 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 this change.
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 from birth to five years because necessary studies are impossible or highly impracticable. This is because this product is not likely to be used in a substantial number of pediatric patients in this group.
We are deferring submission of your pediatric study for ages six to seventeen years for this application because this product is ready for approval for use in adults and the pediatric study has not been completed.
Your deferred pediatric studies required under 505B(a) of the Federal Food, Drug, and Cosmetic Act are required postmarketing studies The status of this postmarketing study must be reported according to 21 CFR 601.70 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. As per your commitment to CBER, dated January 06, 2012, this required study is listed below:
- Deferred pediatric study under PREA to evaluate T.R.U.E. TEST and the seven new allergens in pediatric patients ages six to seventeen.
Final Protocol Submission: June 2012
Study Completion Date: September 2013
Final Report Submission: December 31, 2013
Please submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 103738/5074. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA STN BL 103738/5074. If the information in the final study report supports a change in the labeling, the final study report should be submitted as a supplement. We may also request a supplement if we think labeling changes are needed. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
- Postmarketing Study Commitment Protocol
- Postmarketing Study Correspondence
- Postmarketing Study Commitment – Final Study Report
- Supplement Contains Postmarketing Study Commitments – Final Study Report
For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. Label your annual report an “Annual Status Report of Postmarketing Study Commitments.” The status report for each study should include:
- information to identify and describe the postmarketing commitment,
- the original schedule for the commitment,
- the status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted), and
- an explanation of the status including, for clinical studies, the patient accrual rate (i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Web site (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm). Please refer to the February 2006 Guidance for Industry: Reports on the Status of Postmarketing Studies – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080569.pdf) for further information.
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.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, MD
Division of Vaccines and
Related Product Application
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research