-Charles Hoppes and DMETS supervisory staff found the name and the educational materials acceptable, however, Jerry Phillips still expressed a concern that there may be confusion.  The DMETS review included several comments for the sponsor that will be conveyed in the approval letter.

-DDMAC apparently found the name Wellbutrin XL acceptable from a promotional perspective (no independent review, rather, just a note to this effect in the DMETS review).

 

Mock-up of container labels to facilitate final evaluation of name and labels

-The sponsor provided the mock-up container labels

-These materials were submitted and found to be acceptable.

 

Full response to CMC deficiencies

-We provided a list of deficiencies and the required responses.

-It is my understanding that GSK has fully and satisfactorily responded to all CMC deficiencies, and CMC staff have recommended final approval.

 

 

Adoption of proposed dissolution specifications

-We proposed a dissolution method and specifications.

- The sponsor provided justification for broadening the specification at 4 hours, and OCPB has agreed with this change.

 

Literature search regarding potential drug interactions

-We noted that there are recent in vitro data suggesting that certain SSRIs and antiretroviral drugs may be inhibitors and/or substrates for CYP2B6, the enzyme involved in the hydroxylation of bupropion.  Thus, we requested a literature search regarding this issue, and noted that labeling may need modification, depending on what was found.

-The sponsor conducted a literature search and presented the results, and an argument that clinically significant interactions are unlikely.  Sally Usdin and OCPB supervisory staff agree that literature reports do not confirm significant interactions, not do they rule them out.  Thus, they argue that some statement is needed in Drug Interactions to at least note the possibility of such interactions.  We have asked the sponsor to adopt such a statement, and they have agreed.

 

 

Safety update, including literature update

-We requested a safety update, including an update on worldwide use of Wellbutrin XL and a literature update on this product.

-The sponsor provided a safety update including safety data from 6 ongoing or completed studies (1 pk, 2 comparing effects on sexual functioning, 2 in seasonal affective disorder, and 1 in adult ADHD).  There were 3 SAEs, however, none could be reasonably attributed to drug.  There were 19 discontinuations for adverse events; while for 15 of these the specific event was not listed, we know they did not represent SAEs.  There was no indication of any important new safety findings that would impact on the approvability of this product or on labeling.

-Wellbutrin XL is not approved anywhere at this time, and no published references regarding this product were found.

 

 

2

 

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