Clinical
Review of Safety: NDA 21,515
WELLBUTRIN
XL EXTENDED-RELEASE Tablets (Bupropion HCl)
Sponsor: GlaxoSmithKline
Date
of Correspondence: August 26, 2002
Date
Received: August 26, 2002
Drug
Name: WELLBUTRIN XL
(bupropion
HCl
extended-release)
Drug
Class: Antidepressant
Related
NDAs & IND: 18, 644, 20,358,
IND: 28,676
Dosage
Strengths: 150 mg & 300 mg tablets
I.
Overview & Summary of Safety Conclusions
This
review focuses on the safety profile of WELLBUTRIN XL, an extended-release
formulation of bupropion, which would be administered once-daily. The safety data reviewed derive from 5
completed bioavailability studies and 3 ongoing efficacy trials using WELLBUTRIN
XL. Generally, WELLBUTRIN XL appears to
be reasonably safe and well tolerated.
The safety profile appears to be quite similar to that of the reference
compound, the immediate-release formulation of bupropion. There were no deaths, serious adverse events,
or new/unexpected adverse events reported from the 8 trials reviewed. All adverse events associated with
WELLBUTRIN XL administration have been included in bupropion labeling.
II.
Introduction and Background
A.
Drug Established and Proposed Trade Name, Drug Class, Sponsor’s
Proposed Indication, Dose, Regimens,
Age Group
The sponsor seeks approval for WELLBUTRIN XL (150 mg
and 300 mg tablets), an extended-release formulation of bupropion HCl, for the
treatment of Major Depression in adults.
The sponsor states that WELLBUTRIN XL has been developed to allow for
once-daily dosing, which could enhance convenience, improve compliance, and
provide benefits in safety and tolerability compared with BID and TID dosing
required during treatment with the immediate and sustained-release formulations
of bupropion.
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