V.                 RECOMMENDATIONS

 

1.       DMETS has no objections o 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 the labeling revisions outlined in section III of this review to minimize potential errors with the use of this product.

 

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.

 

DMETS would be appreciate feedback of the final outcome of this consult.  We would be willing to meet with the Division for further discussion, if needed.  If you have further questions or need clarifications, please contact Sammie Beam, Project Manager, at 30-827-3242.

 

            ________________________

            Charlie Hoppes, R.Ph., M.P.H.

            Safety Evaluator

            Division of Medication Errors and Technical Support

            Office of Drug Safety

 

            _________________________

            Alina Mahmud, R.Ph.

            Team Leader

            Division of Medication Errors and Technical Support

            Office of Drug Safety

 

 

STAMPED: APPEARS THIS WAY ON ORIGINAL

 

 

5

 

 

 

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