To my knowledge, there are no other outstanding issues that would preclude the final approval of this NDA.

 

 

2.0  SAFETY UPDATE

 

Additional longer term safety data were available for 1577 patients from a depression study (208) who were previously reported in the NDA and from 1740 new patients (mostly from studies of Wellbutrin SR for (whited out).  The cutoff date for the safety update was 3-31-96.

 

The safety update focused on deaths, serious adverse events, and adverse dropouts.  Dr. Dubitsky reviewed line listings and narrative summaries for pertinent cases and discovered no findings that would preclude the final approval of this product.

 

3.0    FOREIGN REGULATORY STATUS

 

Wellbutrin applications in the UK and Canada have not fared well, due to concerns about human safety, particularly seizures and addiction potential) and about the adequacy of animal studies.  All of these concerns have been addressed in our reviews of this product.

 

4.0    FINAL LABELING

 

The sponsor’s proposed labeling was included in the 5-14-96 submission.  We further modified labeling and resolved any differences in our teleconference on 9-12-96.  The labeling issues were mostly minor and easily resolved.  One important issue for the sponsor was their desire to include in the Pharmacodynamics subsection of Clinical Pharmacology data from animal studies they considered important to understanding bupropion’s clinical actions.  We compromised by permitting language in this statement noting the presumed mechanism of action, i.e., noradrenergic and/or dopaminergic effects, since this approach is consistent with similar language permitted in other recently approved psychotropic drugs.  The mutually agreed upon labeling is included as an attachment to the approval letter.

 

 

5.0    EXPIRATION DATE

 

In our approvable letter, we approved an 18 month expiration date.  In the 5-14-96 response, the sponsor submitted data that they considered supportive of a 24 month expiration date.  We disagree on the usefullness [usefulness] of these additional data, and we conveyed to the sponsor in our 9-12-96 teleconference our view that the expiration

 

 

 

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