March 12, 1996
NDA
20-358
Glaxo
Wellcome Inc.
Attention:
James E. Murray
Director,
Regulatory Affairs
Five
Moore Drive
Research
Triangle Park, North Carolina 27709
Dear
Mr. Murray:
Please
refer to your New Drug Application (NDA) dated and received February 28, 1994,
submitted pursuant to section 505(b) of the Federal Food, Drug and Cosmetic Act
for Wellbutrin* SR (Bupropion Hydrochloride) 50, 100, and 150 mg Sustained
Release Tablets, NDA 20-358, for the treatment of depression.
Reference is also made to an Agency not approvable letter dated May 25, 1995.
We
acknowledge receipt of your resubmission dated September 22, 1995 and to
amendment dated November 6, and 22, 1995.
We
have completed our review of your resubmitted application, and it is approvable. Before the application may be approved,
however, it will be necessary for you to respond to the following items:
CLINICAL
1.
Labeling
Accompanying this letter (ATTACHMENT) is the
Agency’s proposal for the labeling of Wellbutrin* SR. In some cases, our proposed labeling is substantially different
from that proposed in your September 22, 1995 resubmission. One of our major concerns about your
proposed labeling was its failure to adequately emphasize the dose-relatedness
for certain important adverse events and to include incidence data for these
events at the upper end of the bupropion dose range now being recommended. Full explanations for our proposed changes
and requests for additional work on your part in repairing the labeling are
included in our draft of labeling as bracketed comments. We believe our proposed labeling presents a
fair summary of the information available on the benefits and risks of
Wellbutrin* SR. Please use the proposed
text verbatim.
Under 21 CFR 314.50(d)(5)(vi)(b), we request
that you update your NDA by submitting new safety information available for
Wellbutrin* SR. Exactly what will be
needed in terms of a safety update will depend largely on how much additional
information is available. Our review of
the safety of Wellbutrin* SR was based on data from approximately 4100 subjects
and patient exposed to this drug. If,
as is likely, the amount of additional safety information available either
Back a Page
Next Page
Back to Wellbutrin SR® NDA Index Page
Back to Main
Index