NDA 20-358

20

 

 

RECOMMENDATIONS:

 

This NDA is approvable provided the sponsor verifies that the "undegraded" bupropion used in the studies performed contains amounts of impurities similar to those present in the drug which was originally used in the pivotal preclinical studies performed under NDA 18-644.

 

The sponsor should also be requested to submit (or indicate if and when submitted) the following studies which are being used to support proposed labelling changes: (1) the study on effects of bupropion and its metabolites on firing rates of noradrenergic, dopaminergic, and serotonergic neurons in rat brain and (2) the "third" rat cytogenetic study (I am only aware of 2, i.e., the one originally submitted under NDA 18-644, which was positive, and the one submitted with the present NDA, which was negative).

 

My comments on the proposed labelling revisions are made above under "Labelling".

 

(Signature)

Barry N. Rosloff, Ph.D.

 

cc: NDA 20-358

HFD-120

HFD-120/GFitzgerald (Handwritten: G?F 4/7/95)

                /BRosloff (Handwritten: P. David)

rd/ejs/9/30/94

ft/ejs/10/7/94

N:\Rosloff/NDA20358

 

 

 

 

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