STAMPED JUN 3 1994

 

NDA: 20-358                                                                                                                        Submission Date:

                                                                                                                                                April 13, 1993

 

Generic Name, Dose & Formulation: Bupropion Hydrochloride – 50, 100, and 150 mg

Film-Coated Sustained Release (SR) Tablets for Oral Administration

 

                STAMPED: COMPLETED JUN 22, 1994

Brand Name: WELLBUTRIN® SR

 

Sponsor:    Burroughs Wellcome Co

                    Research Triangle Park, NC

 

Type of Submission: Review of Original NDA                                               Reviewer: Safaa Ibrahim

 

 

REVIEW OF ORIGINAL NDA

 

                    Bupropion hydrochloride (WELLBUTRIN) is an antidepressant of the aminoketone class which is not related to tricyclic or monoamine oxidase inhibitor class of 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.

 

                    Here, 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 45-day file/refuse to file meeting was held on May 21, 1993.  The application was fileable from the Division of Biopharmaceutics’ standpoint.  The application was not considered fileable from the viewpoint of other disciplines because of the presence of two new impurities and for which the sponsor has been requested to characterize their toxicity (Appendix I). Overall, then the NDA was considered not fileable and the Division of Biopharmaceutics was requested to return (unreadable) jackets.

 

(Signature 6/23/93)

Safaa Ibrahim, Ph. D

Pharmacokinetics Evaluation Branch

 

RD Initialed by R. Baweja, Ph. D, (Signature 6/23/93)

FT Initialed by N. Fleischer, Ph.D (Signature 6/2/94)

 

 

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