[GSK Logo] GlaxoSmithKline
July
3, 2003
|
Russell G. Katz, M.D., Director Division of Neuropharmacological Drug Products Center for Drug Evaluation and Research Office of Drug Evaluation I Food and Drug Administration HFD-120, WOC2, Room 4049 1451 Rockville Pike Rockville, MD 20852 |
GlaxoSmithKline PO Box 13398 Five Moore Drive Research Triangle Park North Carolina 27709-3398 Tel. 919 483 2100 www.gsk.com |
RE: NDA 21-515; Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets
Response to Approvable Letter: Clinical Pharmacology, CMC, Labeling, Safety
Dear
Dr. Katz:
Reference
is made to our pending New Drug Application for WELLBUTRIN XLTM
Tablets, 150mg and 300mg, a new extended-release formulation of bupropion
hydrochloride. This once-daily formulation
will provide greater convenience to patients currently being treated with
WELLBUTRIN SRŪ (bupropion hydrochloride) Tablets for the treatment of major
depressive disorder. Reference is also
made to the letter from the agency dated June 24, 2003 that stated the
application is approvable and included specific requests that must be addressed
by GlaxoSmithKline (GSK) before the application may be approved. The purpose of this submission is to provide
a complete response to the June 24, 2003 Approvable letter.
The
requests from the June 24th letter are stated below in bold type and
our response follows:
The Wellbutrin XL trademark 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.
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