CONSULTANT RESPONSE

DIVISION OF MEDICATION ERRORS AND TECHNICAL SUPPORT

OFFICE OF DRUG SAFETY

(DMETS; HFD-420)

DATE RECEIVED: 7/11/03

DESIRED COMPLETION DATE: 8/15/03

ODS CONSULT #: 02-0031-4

TO:

Russell Katz, M.D.

Director, Division of Neuropharmacological Drug Products

HFD-120

THROUGH:

Doris Bates

Project Manager, Division of Neuropharmacological Drug Products

PRODUCT NAME:

Wellbutrin XL (Bupropion Hydrochloride Extended-Release Tablets)

150 mg and 300 mg

NDA#: 21-515

NDA SPONSOR: GlaxoSmithKline

SAFETY EVALUATOR: Charlie Hoppes, R.Ph., M.P.H.

SUMMARY: In response to a consult from the Division of Neuropharmacological Drug Products (HFD-120), the Division of Medication Errors and Technical Support (DMETS) conducted a re-review of the proprietary name “Wellbutrin XL” as well as a labeling review of the revised package insert, carton labeling, and container labels for “Wellbutrin XL” patient sample kit.

RECOMMENDATIONS:

1.       DMETS has no objection to the use of the proprietary name, “Wellbutrin XL”.

2.       DMETS has no objections to the risk management plan proposed by the sponsor.  The sponsor should submit “Dear Health Professional” letters and educational materials to the Agency for review and comment when they become available.

3.       DMETS recommends implementation of the labeling revisions outlined in section III of this review to minimize potential errors with the use of this product.

4.       DDMAC finds the proprietary name, “Wellbutrin XL”, acceptable from a promotional perspective.

We consider this a final review.  However, if the approval of the NDA is delayed beyond 90 days from the date of this review, the name must be re-evaluated.  A re-review of the name before NDA approval will rule out any objections based upon approvals of other proprietary and established names from this date forward.

_________________                                                              _________________

Carol Holquist, R.Ph.                                                                 Jerry Phillips, R.Ph.

Deputy Director                                                                        Associate Director

Division of Medication                                                               Office of Drug Safety

Office Of Drug Safety                                                               Center for Drug Evaluation and Research

Phone: (301) 827-3242      Fax: (301) 443-9664                            Food and Drug Administration