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February 13, 2015 Approval Letter - GRASTEK

SUPPLEMENT APPROVAL

Our STN:  BL 125473/49                                                                                                                  

Merck Sharp & Dohme Corp.
Attention:  Nadine Margaretten, Ph.D.
126 E. Lincoln Avenue
Rahway, NJ 07065

Dear Dr. Margaretten:

We have approved your request to supplement your biologics license application for Timothy Grass Pollen Allergen Extract manufactured at your Wiltshire, United Kingdom facility, to include language regarding concomitant dosing with other allergen immunotherapy to the “What Should I Tell My Doctor Before Taking GRASTEK?” section of the US Medication Guide.

We previously approved a Medication Guide for distribution with this product in accordance with 21 CFR Part 208.  We approve the revised draft Medication Guide you submitted on August 20, 2014.

Please note that:

  • this Medication Guide must be reprinted at the end of the package insert [21 CFR 201.57(f)(2)];
  • you are responsible for ensuring that this Medication Guide is available for distribution to every patient who is dispensed a prescription for this product [21 CFR 208];
  • the final printed Medication Guide distributed to patients must conform to all conditions described in 21 CFR 208.20, including a minimum of 10 point text; and
  • you are responsible for ensuring that the label of each container or package includes a prominent and conspicuous instruction to authorized dispensers to provide a Medication Guide to each patient to whom the drug is dispensed, and states how the Medication Guide is provided.

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 this change.

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

If you have any questions regarding the above, please contact the Regulatory Project Manager, CAPT Colleen Sweeney at (301) 796-2640.

Sincerely yours,

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Product Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment:  Approved Final Draft Labeling

 

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