ADDENDUM TO:
Review and Evaluation of
Clinical Data
NDA 20,358
Sponsor: Glaxo
Wellcome
Drug: Wellbutrin
SR (bupropion hydrochloride
sustained
release tablets)
Indication: Depression
Material
Submitted: Response to Approvable
Letter
Correspondence
Date: May 14, 1996
Date
Received: May 15, 1996
I.
Background
NDA 20,358 was submitted on February 28, 1994. The clinical review was completed on
November 14, 1994, and it was declared non-approvable in a letter dated May 25,
1995, because the sponsor failed to provide adequate evidence of clinical
efficacy. Subsequently, based on a
meeting with the firm on August 2, 1995, and further consultation within the
agency, it was decided to consider approvability based on bioequivalence with
the approved immediate-release formulation with the provision that Wellbutrin
SR be labeled with essentially the same safety statements as found in the
labeling for the approved product. The
sponsor responded with a September 22, 1995, submission that included proposed
labeling based on prior discussions. In
turn, we issued an approvable letter dated March 12, 1996, and included, from a
clinical perspective, a request for revised labeling, a safety update, a
foreign regulatory update, and launch promotional material. The current submission comprises the sponsor’s
response.
II.
Safety
Update
A.
Database
This update consists of safety data from seven
studies:
A total of 1577 patients from Study 208, who were reported previously in the NDA and for whom longer-term safety data
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