AD10.0                                Conclusions

 

The data supplied in the protocol 212 supplement to the NDA does not make a convincing case for the efficacy of bupropion sustained-release, nor does it materially affect the conclusions of the main Clinical Review of the NDA regarding efficacy and safety of the drug.

 

 

                                                                                                                                                                                                (signature)

                                                                                                                                                                                                Dan A. Oren, MD

                                                                                                                                                                                                Division of Neuropharmacologic Drug Products

 

NDA 20-358 Addendum

HFD-120 TLaughren/GDubitsky/DOren/PDavid

 

(Handwritten: Note – Received 2-2-95 TPL)

 

4-3-95

I agree that this additional study does not alter the problem of insufficient clinical data to justify the change in dosing recommendations proposed for Wellbutrin SR.  My memo to the file provides my more detailed discussion of the pertinent issues.

 

Thomas P. Laughren, MD

GL, PDP

 

 

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