Public Health Service
Food and Drug Administration
DATE: September 16, 1996
FROM: Thomas P. Laughren, M.D. (initialed
TPL)
Team Leader,
Psychiatric Drug Products
Division of
Neuropharmacological Drug Products
HFD-120
SUBJECT: Recommendation for Approval Action
for Wellbutrin (bupropion) SR
TO: File NDA 20-358
[Note: This memo should be filed with the 5-14-96
resubmission of the NDA.]
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BACKGROUND
I
refer to my previous memos for a more complete background on this NDA:
4-4-95
Recommendation
for non-approvable action
2-8-96
Recommendation
for approvable action
A Brief chronology of this NDA is as follows:
4-13-93
Original
submission of NDA
6-09-93
Issuance
of Refusal of File Letter
2-28-94
Re-Submission
of NDA
5-25-95
Issuance
of Non-Approvable Letter
9-22-95
Re-Submission
of NDA
3-12-96
Issuance
of Approvable Letter
5-14-96
Response
to Approvable Letter
In summary, this NDA is for a sustained release
formulation of bupropion. The sponsor
has failed in independent studies to demonstrate the efficacy of this
formulation, however, since it is essentially bioequivalent to the immediate
release formulation (for key metabolites, at steady state), we are prepared to
approve this new formulation.
The 5-14-96 response to our approval letter
contained replies to all the issues raised in our letter. In addition, we held a teleconference with
the sponsor on 9-12-96 and resolved any remaining differences.
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