DEPARTMENT
OF HEALTH & HUMAN SERVICES Public
Health Service
Food and Drug Administration
Rockville, MD 20857
GlaxoSmithKline
Attention:
Mary E. Martinson,
Director,
Psychiatry Regulatory Affairs, 5.5206
PO
Box 13398
Five
Moore Drive
Research
Triangle Park, NC 27709
Dear
Ms. Martinson:
Please
refer to your new drug application (NDA) dated August 26, 2002, received August
26, 2002, submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act for Wellbutrin XL (bupropion) Extended-Release Tablets, 150 mg and
300 mg. This NDA provides for a new
extended–release formulation of bupropion.
We
also acknowledge receipt of your amendments dated:
December
18, 2002 (2) January
15, 2003 January
24, 2003
February
11, 2003 April
15, 2003 April
17, 2003 (2)
May
30, 2003 June
6, 2003
We
have completed the review of this application as amended, and it is
approvable. Before this application may
be approved, however, it will be necessary for you to address the following comments
and requests.
Proposed Trademark Wellbutrin XL
We
note the submission of your proposed trademark, Wellbutrin XL, for this drug
product. It has been reviewed by the
Office of Drug Safety/Division of Medical Errors and Technical Support and by
the Division of Drug Marketing, Advertising, and Communications, which have no
objections to the proposed trademark.
DMETS does, however, have concerns regarding potential medication errors
occurring among Wellbutrin XL, Wellbutrin SR, Wellbutrin, and Zyban.
The
addition of a modifier (XL) will not guarantee differentiation within the
product line, especially since there will be two extended release formulations
on the market when this NDA is approved (XL and SR). Since the XL and SR are not bioequivalent, they cannot be
interchanged. We are aware that there
are nine other drug products currently using “XL” as a modifier’ (,) however, none of these has another
extended-release formulation that could be confused with the XL formulation.
We
are therefore concerned about the potential for confusion between Wellbutrin
and Wellbutrin XL, based on medication error reports which have shown that
there can be confusion between Wellbutrin and Wellbutrin SR, and about presumed
interchangeability between Wellbutrin SR, Wellbutrin XL, and Zyban:
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