DEPARTMENT
OF HEALTH & HUMAN SERVICES Public
Health Service
Food and Drug Administration
Rockville, MD 20857
NDA
21-515
GlaxoSmithKline
Attention:
Mary E. Martinson
Director,
Regulatory Affairs, Psychiatry
P.O.
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 hydrochloride extended-release)
Tablets.
We
acknowledge receipt of your submission dated July 3, 2003, August 21, 2003, and
August 28, 2003. The July 3, 2003
submission constituted a complete response to our June 24, 2003 action letter.
This
new drug application provides for the use of Wellbutrin XL (bupropion
hydrochloride extended-release) tablets as a new extended-release formulation
of bupropion.
We
have completed our review of this application, as amended. It is approved, effective on the date of
this letter, for use as recommended in the agreed-upon labeling test.
The
final printed labeling (FPL) must be identical to the enclosed labeling (text
for the package insert, text for the patient package insert, and immediate
container and carton labels). Marketing
the product(s) with FPL that is not identical to the approved labeling text may
render the product misbranded and an unapproved new drug.
Please
submit an electronic version of the FPL according to the guidance for industry
titled Providing Regulatory Submissions in Electronic Format – NDA. Alternatively, you may submit 20 paper
copies of the FPL as soon as it is available but no more than 30 days after it
is printed. Individually mounted 15 of
the copies on heavy-weighted paper or similar material. For administrative purposes, designate this
submission “FPL for approved NDA 21-515.” Approval of this submission by FDA is not required before the
labeling is used.
The
expiration date presently approved for Wellbutrin XL 150 mg and 300 mg Tablets
in the 7 and 30 count bottle is 12 months.
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