Division of Medication Errors and Technical Support

Office of Drug Safety

HFD-420; Parklawn Rm. 6-34

Center for Drug Evaluation and Research

 

 

PROPRIETARY NAME REVIEW

 

 

 

DATE OF REVIEW:  July 29, 2003

 

NDA NUMBER:        21-515

 

NAME OF DRUG:     Wellbutrin XL (Bupropion Hydrochloride Extended-Release Tablets)

                                    150 mg and 300 mg

 

NDA HOLDER:         GlaxoSmithKline

 

 

I.                   INTRODUCTION:

 

This consult was written in response to a request from the Division of Neuropharmacological Drug Products (HFD-120) for a re-review of the proprietary name, “Wellbutrin XL” as well as a labeling review of the revised proposed professional and patient package insert, container labels, and carton labeling for “Wellbutrin XL”.  “Wellbutrin XL” is a new extended-release formulation that is given once daily.  DMETS previously reviewed the proposed proprietary name “Wellbutrin XL” (ODS Consult 02-0031) and found it acceptable on August 31, 2002.  Comments were also provided by DMETS regarding the “Wellbutrin XL” container labels and carton labeling (ODS Consult 02-0031-1) on December 20, 2002 and again on April 2, 2003 (ODS Consult 02-0031-02 and 02-0031-03).  At DMETS’ request, the sponsor has also provided a communication plan, “...to educate healthcare professionals and patients on the appropriate use of Wellbutrin XL with respect to other marketed dosage forms of bupropion hydrochloride.”  The sponsor commits to submit any reported actual or  potential domestic medication error reports associated with Wellbutrin XL to the Agency within 15 minutes or receipt.

 

Other bupropion hydrochloride formulations already exist in the U.S. market.  The immediate-release formulation (Wellbutrin), was approved by the Agency on December 30, 1985.  The extended-release formulations, Wellbutrin and Zyban, were approved by the Agency on October 4, 1996 and May 14, 1997, respectively.

 

PRODUCT INFORMATION

 

“Wellbutrin XL” is the proposed proprietary name for bupropion hydrochloride extended-release tablets.  It is indicated for the treatment of major depressive disorder.  “Wellbutrin XL” is available as a 150 mg and 300 mg tablet.  The usual adult target dose of “Wellbutrin XL” is 300 mg/day, given once daily in the morning.  However, dosing with “Wellbutrin XL” should begin at 150 mg/day given as a single daily dose in the morning.  If the 150 mg initial dose is adequately tolerated by day 4, then an increase to the target dose of 300 mg/day may be given.  The maximum dose of “Wellbutrin XL” is 450 mg/day, which can be given as a single or divided dose.

 

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