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October 16, 2014 Approval Letter - T.R.U.E. TEST

Our STN:  BL 103738/5118                                                  

SmartPractice Denmark ApS
Attention:  Ms. Kim Sullivan
3400 East McDowell Road
Phoenix, AZ 85008

Dear Ms. Sullivan:

We have approved your request to supplement your biologics license application for the Thin-Layer Rapid Use Epicutaneous Patch Test (T.R.U.E. TEST®), manufactured at your Hillerød, Denmark facility, to include changes in excipient and dose strengths for Neomycin sulfate, Potassium dichromate and Fragrance mix and a change in declared labeled dose for Thiuram mix. 

Under this approval, the following changes will be made.

  1. The current Neomycin sulfate formulation, 0.23 mg/cm² in methylcellulose (MC), will be replaced with a 0.60 mg/cm² Polyvidone (PVP) formulation.
  2. The current Potassium dichromate formulation, 0.023 mg/cm² hydroxypropyl cellulose (HPC), will be replaced with a 0.054 mg/cm² PVP formulation.
  3. The current Fragrance mix formulation, 0.430 mg/cm² with β-cyclodextrin/HPC, will be replaced with a 0.50 mg/cm² β-cyclodextrin/PVP formulation.
  4. The current Thiuram mix patch formulation, 0.025 mg/cm² PVP, will be replaced with a 0.027 mg/cm² PVP formulation.

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 Advertising and Promotional Labeling Branch at the following address:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD  20993-0002

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.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

Jay Slater, MD
Director
Division of Bacterial, Parasitic
and Allergenic Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment:  Approved Final Draft Labeling