NDA 20-358 |
18 |
3) Page 15-16 (“Carcinogenesis, Mutagenesis, Impairment of Fertility”)
The sponsor wishes to change the statement that bupropion was positive in a cytogenetic study in rats to say that it was only positive in 1 of 3 studies. I am only aware of 2 studies (1 reviewed under NDA 18-644; the other reviewed above; bupropion was positive only in the former); the sponsor should identify the 3rd study. I am not sure if characterizing the effect as “weak” in the positive study is correct; an increase in chromosomal aberrations of 2-3x control was seen. The route of administration (oral) should be stated. A revised statement might read: “Bupropion caused an increase in chromosomal aberrations only at the highest dose (300 mg/kg/day p.o.) in one of two (or three if documented by sponsor) rat cytogenetic studies.”
4) Page 28 (“Lethal Doses in Animals”)
Although the sponsor has not required a change in this section, the utility of giving animals LD50 values and toxic signs is not clear. (The production of seizures in animals and humans is discussed elsewhere in the labelling).
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