STAMPED: DUPLICATE

[GSK Logo] GlaxoSmithKline

 

STAMPED: RECEIVED AUG 29 2003 DDR-120 / CDER

STAMPED: RECEIVED AUG 29 2003 MEGA/CDER

STAMPED: NEW CORRESPONDENCE

 

August 28, 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 Request: Updated Educational Communication Plan for Wellbutrin XL

 

Dear Dr. Katz:

 

Reference is made to our pending New Drug Application for Wellbutrin XL^TM Extended-Release Tablets, 150 mg and 300 mg, a new extended release formulation of bupropion hydrochloride for the treatment of major depressive disorder.  Reference is also made to the letter from the agency dated June 24, 2003 stating the NDA was approvable and included specific requests that needed to be addressed by GlaxoSmithKline (GSK) before the application may be approved.  GSK submitted a complete response to the approvable letter on July 3, 2003.

 

Included in the response to the NDA approvable letter was a proposed Educational Communication Plan directed to healthcare providers and patients describing the appropriate use of Wellbutrin XL^TM and a commitment for reporting medication errors associated with Wellbutrin XL^TM.  As requested by the FDA, the Communication Plan focuses on the potential for confusion between the various formulations of bupropion: Wellbutrin Tablets, Wellbutrin SR Sustained-Release Tablets, Wellbutrin XL Extended-Release Tablets, and Zyban Sustained-Release Tablets (as an aid to smoking cessation).

 

This Educational Communication program was discussed in a telephone conversation on August 27, 2003 with Richardae Taylor and Robbin Nighswander of the Division.  In the discussion, it was requested that GSK provide an updated version of the communication plan and the timeline for the implementation of the proposed educational activities.

 

The purpose of this correspondence is to provide the updated version of the Communication Plan provided in the July 3^rd correspondence (included in Attachment1).  This plan is similar to that outlined previously with additional information describing

 

 

 

 

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