Russell G. Katz, M.D.

July 3, 2003

Page 5

 

bupropion.  Therefore we recommend that you conduct a thorough search of the literature, as well as searching adverse event reports for bupropion, to evaluate the potential for pharmacokinetic and/or pharmacodynamic (adverse event) drug interactions with bupropion and inhibitors/substrates such as paroxetine, sertraline, fluvoxamine, norfluoxetine, efavirenz, ritonavir, and nelfinavir.  Based on these literature results, an in vivo drug interaction study may be necessary.

 

In addition, we have made specific changes in the revised labeling appended to this letter.  Please address these changes in your complete response.

 

Item 6 contains the results of a search of the literature and of GSK’s adverse event database to evaluate the potential for pharmacokinetic and/or pharmacodynamic drug interactions with bupropion and inhibitors/substrates such as paroxetine, sertraline, fluvoxamine, norfluoxetine, efavirenz, ritonavir, and nelfinavir.  Item 2 contains the revised product labeling.

 

Clinical / Clinical Safety

 

We have completed our review of the clinical safety information and proposed package insert as provided in your NDA.  Our comments are incorporated into the revised labeling appended to this letter, as bracketed comments, text insertions [underlined], or deletions [strikethrough].  Please address these changes specifically in your complete response.

 

Item 2 contains the revised package insert.

 

Request for Safety Update

 

In your complete response to this letter, please include a safety update as described in 21 CFR 314.50(d)(5)(vi)(b).

 

A safety update report is included in Item 9.

 

Literature Update

 

Wellbutrin XL is not a marketed product nor is it approved for use in any country worldwide at this time.

 

 

 

 

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