MEMORANDUM            Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Drug Evaluation and Research

 

 

DATE:                    February 26, 1996

 

FROM:                   Paul Leber, M.D.

                                Director,

                                Division of Neuropharmacological Drug Products

                                HFD-120

 

SUBJECT:                Approvable Action: NDA 20-358

                                Wellbutrin SR for Depression

 

TO:                         File NDA 20-358

                                                &

                                Dr. Robert Temple

                                Director, ODE 1

 

This memo convey’s [conveys]  the Division’s recommendation that the NDA for Wellbutrin SR¹ be declared approvable.

 

Efficacy

 

The conclusion that Wellbutrin SR will be effective in use derives from a demonstration of its “bioequivalence” to the marketed IR formulation when each is given at a daily total dose of 300 mg (when the IR is given tid and the SR bid).

 

It is impossible, however, to draft recommendations for use of the SR product that make it bioequivalent to the IR product over the full range of doses at which the latter is recommended for use.

 

This occurs because 1] Wellbutrin (the approved IR product) is effective at daily dose of 300 to 450 mg and 2] the sponsor’s formulations of Wellbutrin SR (50 mg, 100 mg and 150 mg) cannot be combined in a manner

 

 

 

 

¹ The NDA was first submitted on 4/13/93.  A refuse to file action was taken and the application was not resubmitted until 2/28/94.  Upon review it was found (5/25/95) not approvable (efficacy was not demonstrated in the clinical trials conducted under the conditions of use recommended in the product’s proposed labeling: 150 to 300 mg daily dose given bid).

 

 

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