MEMORANDUM           Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Drug Evaluation and Research

 

 

DATE:                    February 8, 1996

 

FROM:                   Thomas P. Laughren, M.D. (initialed)

                                Director,

                                Division of Neuropharmacological Drug Products

                                HFD-120

 

SUBJECT:              Recommendation for Approval Action for Wellbutrin (bupropion) SR

 

TO:                         File NDA 20-358

                                [Note:  This memo should be filed with the 9-22-95 re-submission of the NDA.]

 

 

1.0     BACKGROUND

 

I refer to my 4-4-95 memo for a more complete background on this NDA.  In summary, this NDA is for a sustained release formulation of bupropion, a drug which is currently approved in an immediate release formulation for the treatment of depression (NDA 18-644), NDA-20358 was originally submitted 4-1393.  The NDA was not filed due to chemistry and pharmacology deficiencies.  After the repair of these deficiencies, the NDA was re-submitted 2-28-94.  The program included both clinical and bioequivalence trials.  The labeling submitted with the application proposed dosing in a range of 150-300 mg/day, i.e., a lower dose range than that recommended for the currently available SR [IR?] product.  Unfortunately, the clinical trials failed to demonstrate effectiveness for the SR product in the lower dose range studied, and a non-approvable letter was issued 5-25-95.  However, in that letter, we acknowledged that the sponsor had demonstrated in their PK studies the bioequivalence of the SR and IR formulations (when dosed bid for the SR vs tid for the IR), with regard to both extent and rate of absorption.  In fact, we indicated that we would be willing to approve the SR formulation in a dose range of 300-400 mg/day, providing the sponsor submitted labeling consistent with this recommendation.

 

The 92—295 re-submission of this NDA responds to the issues raised in our 5-25-05 non-approvable letter.  From a clinical standpoint, the sponsor is now recommending for Wellbutrin SR a maximum dose of 400 mg/day, i.e., a dose close to the currently recommended maximum dose of 450 mg/day.  It was decided internally that, given the dosing recommendation, we could rely on the IR/SR bioequivalence

 

 

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