STAMPED:  MAR 21 1995

NDA:      20-358                                                                                                                                                                                                     Submission Dates:

                                                                                                                                            February 28, 1994

                                                                                                                                            August 1, 1994

 

Generic Name, Strength(s), and Formulation:                                      Bupropion hydrochloride (HCL) 50, 100,                                     and 150 mg sustained-release (SR) tablets                                                                                       for oral administration.

 

Brand Name:         WELLBUTRIN® SR                                             

 

Sponsor:                                Burroughs Wellcome Co.

                                Research Triangle Park

                                North Carolina

 

Type of Submission:   Review of NDA                                                Reviewer: Safaa Ibrahim, Ph.D.

 

SYNOPSIS:

 

Bupropion hydrochloride (WELLBUTRIN®) is an antidepressant of the aminoketone class which is not related to the tricyclic or tetracyclic antidepressants.  it is currently marketed as 75 and 100 mg immediate release (IR) tablets for oral administration.  The usual adult dose is 300 mg per day, given TID.  The IR product was approved under NDA #18,644 on December 30, 1985.

 

The sponsor is submitting a new application (NDA #20-358) for the sustained release (SR) formulation to allow for twice daily dosing regimen and thus improve patient compliance as compared to TID dosing obtained through the currently available IR tablets.  The SR product will be available as 50, 100, and 150 mg film-coated tablets for oral administration.

 

The pivotal biobatches for the three strengths of the SR tablets were made by Burroughs Wellcome Company in Greenville, N.C.  Further, manufacturing of these three strengths will also occur at the Greenville facility.

 

Unless otherwise indicated any general inferences drawn below pertain to bupropion, its active metabolites, and the pharmacologic activity weighted composite (PAWC).

 

A multiple dose study involving the immediate release (IR) tablets indicated that steady state plasma levels were achieved within 8 days for bupropion and its active metabolites (306U73, 494U73, and 17U67); n-22.  At steady state, mean AUC_0-60hr was about 17, 7, and 1.5 times larger for 306U73, 494U73, and 17U67, respectively than for bupropion.  Bupropion and its active metabolites (306U73, 494U73, and 17U67) exhibit linear kinetics over the dosing range of 300 mg/day to 450 mg/day of the parent drug, which covers the therapeutic range for the IR

 

 

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