9.0
Labeling Review
A labeling review is not included because this review recommends non-approval.
10.0
Conclusions
The
data supplied in this NDA does not make a convincing case for the efficacy of
bupropion sustained-release as an antidepressant at any of the dosages
employed. The presented trials suggest
that when used as indicated in the protocols bupropion sustained-release is a
reasonably safe medication. The absence
of a clearly-defined benefit from bupropion sustained-release, however, argues
against its approvability for the treatment of depression.
11.0
Recommendations
On
the basis of the data set available, this application does not meet criteria
for approvability for the treatment of depression.
(Signature)
Dan A. Oren
Division of
Neuropharmacologic Drug Products
NDA
20-358
HFD-120:
TLaughren GDubitsky/DOren PDavid
(handwrittern)
4-3-95
Typed:
While
I believe the sponsor has demonstrated bioequivalence for the Wellbutrin IR and
SR formulations, I agre that they have not provided clinical evidence to
justify the proposed change in dosing recommendations for this drug. Consequently, I agree that the application,
as submitted with proposed labeling, is not approvable. My memo to the file provides my more
detailed discussion of the pertinent issues.
(Signature: Thomas P. Laughren, MD
([six or G]L, PDP)
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