Barry
N. Rosloff, Ph.D.
9/29/94
Pharmacologist Review of NDA
20-358
Original Summary
SPONSOR: Burroughs Wellcome Co.
3030 Cornwallis
Road
Research
Triangle Park, NC 27709
DRUG: bupropion
(Wellbutrin®) sustained release tablets
CATEGORY: antidepressant
RELATED
NDA: NDA
18-644 (NDA for marketed immediate release formulation, same sponsor as
present).
NEW
PRECLINICAL STUDIES SUBMITTED:
(N.B.
These studies were performed as bridging studies to support the sustained
release formulation; see “Summary” section for details.)
1)
90
day p.o. toxicity in rats
-
Performed
by sponsor
-
BIN
numbers IN2730 and 3M2498A for degraded and undegraded drug, resp.
2)
Segment
II reproduction in rats
-
Performed
by Research Triangle Institute
Research Triangle Park, NC 27709-2194
-
BIN
numbers 3U6028A, B, and C for degraded drug and 3U6029 for undegraded drug.
3)
Ames
tests
-
Performed
by (whited out)
-
BIN
used not stated; analysis sheets give BIN numbers 3X6011 A-F for “Wellbutrin plus
degradants” but it is not clear if these were used in the studies.
4)
In vivo
cytogenetic study in rats
-
Performed
by sponsor and by (whited out)
-
BIN
number 3U6007E (not clear if this applies to degraded or undegraded drug).
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