proposed dose range of 300-400 mg/day.  As all of the lower dose patients were included in the 1% and 5% ADR tables, this creates an artificially inflated denominator.

 

The narrative section reflects the experience with BSR as opposed to BIR.  The narrative states that 4320 patients were exposed to Wellbutrin SR; however, 4202 patients can only be accounted for in the dat [data] that was submitted for review.

 

III.     Conclusions and Recommendations

The newly proposed labeling submitted by the sponsor is accurate in-so-far as what is presented.  The sponsors do not mention the efficacy study results for BSR, (which were not encouraging) and they do not mention that the BSR formulation was approved on bioequivalence alone.  The safety section removes most of the repeated warnings regarding seizures and merely refers the reader to the “Warnings” section.  The only reference to seizure risk in the patient information section was removed.

 

One should consider presenting the data for the patients in the recommended dose range in the ADR tables instead of including the patients in the lower dose ranges.  The current presentation artificially inflates the denominator and produces lower AE rates than those that would represent the recommended use.

 

 

(signature 2/1/96)

Paul J. Andreason, M.D.

 

cc:   NDA#20.358         HFD-120         HFD-120/PAndreason         Dubitsky         TLaughren         PDavid

Handwritten: 2-1-96 I agree that the labeling needs much work, and I have developed a draft of labeling that is substantially different than what sponsor has provided.  See draft labeling and my memo in file for details.   Thomas P Laughren , MD GL, PDP

 

 

 

Page 3    NDA 20,358

 

Back a Page
Next Section - Review of Chemistry, Manufacturing, and Controls
Back to Wellbutrin SR® NDA Index Page
Back to Main Index