NDA 21-515 Approval Letter 5
described. Should any report or finding be judged
important, a copy (translated as required) should be submitted for our review.
Labeling (Package Insert and Container Labeling)
1.
In
addition to responding to the points listed above, it will be necessary for you
to submit draft labeling revised as shown in the attachment to this
letter. We believe the attached draft
labeling presents a fair summary of the information available on the benefits
and risks of Wellbutrin XL (bupropion) Extended Release Tablets in the
treatment of major depressive disorder.
Please
use the proposed text verbatim. You
will see that we have proposed a number of changes to the draft labeling as
updated in your January 24, 2003 submission, and explanations for these changes
are provided n the bracketed comments embedded within the proposed text. Division staff are willing to discuss these
proposed changes in detail and to meet with you to discuss any disagreements
you may have with any part of the proposed labeling format or content.
2.
In
addition, we have the following comments with respect to the container labeling
for the new drug product:
A.
Container
Labeling (150 and 300 mg tablets, packages of 7 and 30 tablets)
1.
The
phrase “extended-release tablets” should be included within the brackets of the
established name so that it reads: (bupropion hydrochloride extended-release
tablets)
2.
The
phrase “extended-release tablets” should appear in the same font as “bupropion
HCl” and should be at least 1/2 the size of the proprietary name.
3.
The
logo around the “XL” is distracting and should be deleted, or moved to a less
prominent location. The strengths, 150
mg” and “300 mg”, on the lids of the cartons that contain 12 bottles of 7
tablets should be made more prominent by, for example, increasing the font
size.
B.
Carton
Labeling (carton containing 12 bottles of 7 tablets)
1.
Please
see comments A.1. through A.3. above.
C.
Patient
Sample Kit (1 bottle of 150 mg strength (7 tablets) and one bottle of 300 mg
strength (7 tablets))
1.
The
150 mg tablets bottle (7 tablets) and the 300 mg tablets bottle (7 tablets)
should not be packaged together. A dose
of 300 mg per day is not initiated until Day 4 of dosing; a patient may easily
confuse the two bottles and mistakenly take the wrong dose. For example, a patient may accidentally
ingest a 300 mg tablet on Day 1 of dosing.
2.
Also,
the tablets are similar in appearance (creamy-white to pale yellow), increasing
the potential risk of taking the wrong strength at the wrong time when they are
packaged together. This would increase
the risk of seizures as well as other side effects such as agitation, insomnia,
and psychosis.
3.
The
[blacked out] should be removed from the front panel, since it
distracts attention
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