Russell
G. Katz, M.D.
July
3, 2003
Page 8
Introductory promotional materials are currently under development and are not yet available. However, it is our understanding from discussion with DDMAC that FDA review of promotional materials prior to use is optional. As required by regulation, all promotional pieces will be filed to the NDA via Form FDA 2253 at the time of initial dissemination.
NDA Amendment Organization
This amendment is provided in accoradnce with the Guidance for Industry, Providing Regulatory Submissions in Electronic Format-NDAs (January 1999) and subsequent agreements. Please see Guide to Reviewers for detailed information about this electronic submission.
Review Aids/Copies
Three paper “Review” copies will be provided of this amendment to Dr. Doris Bates for use by the review team; the paper copies are labeled REVIEW COPY – NOT FOR ARCHIVE. The literature references included as pdf files in Item 6 of the electronic submission have not been included in the review copies. The contents of the paper review copies were printed from the electronic archive pdf files, and are therefore identical to the contents of the electronic archive copies.
Field Copy
In accordance with 21 CFR 314.50(1)(3), GlaxoSmithKline will provide a Filed Copy of this Amendment to the FDA Atlanta District. The Field Copy is a true copy of this application.
Closing Information
So that we can be accessible and responsive to your requests during the review process, please note that I can be reached at the following numbers at any time to discuss this application:
Phone: (919) 483-3763
FAX: (919) 315-8319
In my absence, please contact Mr. James Murray, VP Regulatory Affairs, Psychiatry and Neurology (Phone: 919-483-5119) concerning this application.
If there are any questions about the Chemistry, Manufacturing and Controls Section of this application, please contact Mr. Leo Lucisano, CMC Regional Director, Regulatory Affairs, at (919) 483-5848.
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