Left
Ventricular Dysfunction Population Subgroup (p. 4):
This
statement came from currently approved labeling; I agree it is vague and
difficult to interpret without reference to control data. I have embedded a comment asking the sponsor
to provide more data and explanation.
Drug
Interactions (p. 14):
My
impression is that the cytochrome P450s are not involved in bupropion’s
metabolism (mostly reduction rather than oxidation), but I don’t think we know
anything about whether or not they may inhibit any of the cytochromes. I have embedded a comment asking the sponsor
to comment on this question and provide any pertinent data.
I’ve
slightly modified the second paragraph to suggest simply that other drugs may
either enhance or inhibit bupropion’s metabolism.
Carcinogenesis,
etc and Pregnancy (pp. 14-15):
Several
changes have been made here pertinent to the questions raised and comments on
these sections.
cc:
HFD-120/DivFile
HFd-120/TLaughren/PLeber/PDavid
DOC:
MEMBRPSR.AE2
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