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[Logo - CDER] CHEMISTRY REVIEW TEMPLATE
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Chemistry Assessment Section
Bupropion Hydrochloride was originally investigated
under IND 13, 845. Bupropion is a
racemate and is a member of the aminoketone class of compounds. Bupropion Hydrochloride is currently
approved for use in Welbutrin [Wellbutrin] SR®
Tablets (NDA 20-358) and the Wellbutrin Tablets (NDA 18-644). The applicant included very limited
information on the drug substance in this application and references [blacked
out] for the manufacture and controls of the drug substance. The drug substance is described as a white
crystalline solid that is highly soluble in water and has a bitter taste. Bupropion hydrochloride is designated as
(±)-1-(3-chlorophenyl)-2-[1,1-dimethylethy) amino]-1-propanone
hydrochloride. The molecular
formulation for is C13H18ClNO·HCl and the molecular
weight is 276.2. A letter of
authorization is provided on page 2 of volume 4.1. There is no information pertaining to the synthesis of the drug
substance outlined in this application.
The applicant intends to adopt the current USP (effective January 1,
2003) specifications for the drug substance[.]
The drug product, Wellbutrin XLTM Tablets
is an antidepressant designed for once a day administration. The drug product, Wellbutrin XLTM,
is a [blacked out] tablet consisting of a [blacked out]. Together, the coatings form a [blacked
out] that is responsible for the release of the drug substance,
bupropion hydrochloride. All
ingredients used in the manufacture of the drug product with the exception of [blacked
out]. Black Ink are either USP
or NF grade. The applicant indicates
that the drug product will be available in two dosages 150 mg and 300 mg and
will be manufactured at the Biovail Lifesciences in Steinbach, CA. The 150 mg tablets are creamy white to pale
yellow round tablet imprinted with “Wellbutrin XL 150” in black ink on one side
and plain on the other side. The 300 mg
tablets are creamy white to pale yellow round tablets imprinted with “Wellbutrin
XL 300” in black in on one side and plain on the other side. The tablets will be packaged in 7 count [blacked
out] bottles for physician samples and 30 count [blacked out]
for commercial distribution. Both the
30 and 7 count bottles will be packaged with a [combination]
[blacked out] and closed with a [blacked out] child
resistant closure.
The applicant proposed the proprietary name
Wellbutrin XLTM Tablets for the drug product. The Office of Post-Marketing Drug Risk
Assessment (OPDRA) has not posed any objections to the use of this name.
A. Description of How the Drug Product is Intended to be Used
Wellbutrin XLTM is being developed for
the treatment [of] major depressive
disorder. It’s extended release
formulation is designed for patients that suffer from MDD. The applicant has provided a confirmatory
bioequivalence study comparing Wellbutrin XLTM Tablets with the
currently marketed Wellbutrin® Tablets.
The applicant indicates that administration should begin with the 150 mg
dose and if that dose is well tolerated then the patient should increase to the
300 mg/day target dose. The applicant
further indicates that an increase to the maximum daily dose of 450 mg/day may
be given as a single dose or divided dose.
Page 8 of 4444
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