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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