Russell G. Katz, M.D.

July 3, 2003

Page 2

 

DMETS recommends the creation and implementation of a risk management 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 plan should be implemented both before and after product launch.  In addition, once this NDA is approved, you should submit any medication error reports associated with Wellbutrin XL to the Agency within 15 days of their receipt by your firm, whether the error is actual or potential.

 

Item 20 contains a proposed communication plan to educate healthcare professionals and patients on the appropriate use of Wellbutrin SL with respect to other marketed dosage forms of bupropion hydrochloride.  Included is a list of key messages to provide clear directives and a table of proposed communication vehicles along with a proposed timeline for these communications.  The document also describes GSK’s commitment to report any medication errors associated with Wellbutrin XL to the Agency within 15 days of their receipt, whether the error is actual or potential.

 

It is CDER policy that proposed proprietary names and their associated labels must be evaluated approximately 90 days prior to the anticipated approval of the NDA.  Full re-evaluation of the trademark will be necessary prior to final approval of the NDA.  Please assure that a complete set of mock-up container labels and labeling are provided, featuring the proposed trademark.

 

Item 2 contains the labeling for the containers and cartons, featuring the proposed trademark.

 

Chemistry, Manufacturing and Controls (CMC)

 

1.      Please provide a description of the bulk packaging process for the drug product.

 

A description of the bulk packaging process is included in Item 4, Section P7.1.5.

 

2.      In your sampling plan for the drug product, you indicate that representative samples of the drug product will be taken at the end of the manufacturing process to serve as a source of samples for testing.  Please be advised that samples should be taken throughout the manufacturing process and not just at the end.  Please provide an updated sampling plan which adequately tests samples of product from the beginning, middle, and end of the process.

 

 

 

 

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