1.0
Material Utilized in Review
1.1
Material From NDA
The
following is a list of specific items reviewed:
|
Volume |
Submission Date |
Material |
|
2.13 |
February 28, 1994 |
Summary
of Phase 2 trial #203 |
|
2.14-2.19 |
February 28, 1994 |
Study
reports for trial #203 |
|
2.20 |
February 28, 1994 |
Summary
of Phase 2 trial #205 |
|
2.21-2.28 |
February 28, 1994 |
Study
reports for trial #205 |
|
2.29,
2.46 |
February 28, 1994 |
Integrated
summary of effectiveness |
|
2.29,
2.46 |
February 28, 1994 |
Integrated
summary of safety |
|
2.47-2.59 |
February 28, 1994 |
Case
report forms |
|
|
June 6, 1994 |
Response
to request for additional efficacy data |
|
|
June 29, 1994 |
Additional
case report forms submitted |
|
|
June 29, 1994 |
Response
to request for demographic and exposure data |
|
|
July 14, 1994 |
Revised
labeling |
|
5.1,
5.3, 5.8-5.11 |
July 14, 1994 |
Study
report for Phase 3 trial #208 |
|
|
July 29, 1994 |
Narrative
summaries of premature discontinuation |
|
|
August 1, 1994 |
Response
to request for adverse effect data |
|
|
August 2, 1994 |
Response
to request for relative risk data |
|
|
August 18, 1994 |
Additional
case report forms submitted |
|
|
September 9, 1994 |
Response
to request for additional demographic data |
|
|
September 12, 1994 |
Worldwide
marketing and application history submitted |
Safety
issues were addressed primarily via the integrated summary of safety,
supplemented by examination of individual study reports and case report forms.
1.2
Related Reviews
The
division files for INDs (whited out) (Burroughs Wellcome’s
commercial IND’s for Wellbutrin and bupropion sustained-release tablets) were
consulted during the course of this review.
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