STAMPED: DUPLICATE

[GSK Logo] GlaxoSmithKline

 

STAMPED: RECEIVED AUG 22 2003 CDR/CDER

STAMPED: RECEIVED AUG 25 2003 DDR-120 / CDER

STAMPED:  ORIGINAL AMENDMENT

 

 

August 21, 2003

 

Russell G. Katz, M.D., Director                                                                   GlaxoSmithKline

Division of Neuropharmacological Drug Products                                          PO Box 13398

Center for Drug Evaluation and Research                                                     Five Moore Drive

Office of Drug Evaluation I                                                                          Research Triangle Park

Food and Drug Administration                                                                      North Carolina 27709-3398

HFD-120, WOC2, Room 4049                                                                    

1451 Rockville Pike                                                                                     Tel. 919 483 2100

Rockville, MD 20852                                                                                   www.gsk.com

 

RE:   NDA 21-515; Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets

         Response to FDA Comment: Labeling

 

Dear Dr. Katz:

 

Reference is made to our pending New Drug Application for WELLBUTRIN XL^TM Tablets, 150 mg and 300 mg, a new extending release formulation of bupropion hydrochloride.  Reference is also made to the email communication received August 19, 2003 from Richardae Taylor, Project Manager for Wellbutrin XL, that included revised wording for the package insert and Patient Information leaflet for WELLBUTRIN XL.

 

We have reviewed the proposed changes and find them acceptable.  The purpose of this correspondence is to submit a draft revised package insert and Patient Information leaflet that includes the following changes as requested by FDA:

 

Package Insert:

 

[blacked out]

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page