Memorandum
Department of
Health and Human Services
Public Health
Service
Food and Drug
Administration
DATE: September 30, 1996
FROM: Paul Leber, M.D.
Director
Division of
Neuropharmacological Drug Products
HFD-120
SUBJECT: Approval Action: NDA 20-358
Wellbutrin SR
for Depression
TO: File NDA 20-358
&
Dr. Robert
Temple
Director, ODE 1
This
memo provides my formal recommendation that the NDA for Wellbutrin SR be
approved. My most recent comments on
the issues affecting approval of this NDA were presented in my memorandum to
the file of February 26, 1996.
The
regulatory actions affecting the NDA since it was declared approvable are
summarized in Dr. Laughren’s memorandum of 9/16/96.
Recommendation:
The
NDA should be approved with the understanding that the product will be marketed
under the labeling attached to the approval action letter.
signature
Paul Leber, M.D.
September 30, 1996
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