Leber: Wellbutrin SR approvable

page 3

 

 

illogical.

 

In sum, the advantages, if any, of Wellbutrin SR to the currently marketed IR formulation of bupropion have not been demonstrated.  Indeed, there is no fair comparison of the IR and SR formulations under the conditions of use recommended in the proposed labeling for each product.

 

Nevertheless, it is possible to recommend Wellbutrin SR for approval under appropriately conservative and truthful labeling.

 

Recommendation:

 

The NDA should be declared approvable with the understanding that the product will be marketed under the labeling developed by Dr. Laughren and attached the approvable action letter.

 

 

                                (Signature)

Paul Leber, M.D.

February 26, 1996

 

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