lack of studies on addictive potential, and questions regarding the adequacy of animal studies). This plan for investigation in the U.K. has not been pursued.
In sum, it seems that none of the foreign concerns
are new; most, if not all, emerged prior to U.S. approval of Wellbutrin.
IV. Introductory Promotional Materials
No promotional materials were submitted at this time. These will be drafted and submitted to the agency after concensus [consensus] on labeling but prior to market introductions.
V. Labeling
Product labeling proposed by the sponsor was reviewed and edited. However, since labeling will require further modification, the edited version is not included as part of this review but will be forwarded to the Team Leader under separate cover.
Signature
Gregory M. Dubitsky, M.D.
August 9, 1996
cc: NDA 20,358
HFD-120
HFD-120/GDubitsky
PAndreason
TLaughren
PDavid
(Handwritten
note:)
8-31-96
I
agree that this NDA can now be approved.
We still need to get agreement with GW on final labeling, and also
expiration date and dissolution speed. (One
word unreadable) were to file for more detailed response.
Thoumas
P. Laughren, MD
TL,
PDP
Page 4
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