DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

REQUEST FOR CONSULTATION

TO: (Division/Office): Drs. Uppoor and Yasuda, HFD-860

FROM: Dr. Bates, HFD-120 (For Dr. Andreason)

Date: July 8, 2002

IND NO. 28,686

NDA 21-515

TYPE OF DOCUMENT

NDA resubmission

DATE OF DOCUMENT

July 3, 2003

NAME OF DRUG

Wellbutrin XL (Bupropion HCl)

PRIORITY:

3S

CLASSIFICATION OF DRUG

antidepressant

DESIRED COMPLETION

DATE: August 15, 2003

NAME OF FIRM: GlaxoSmithKline

REASON FOR REQUEST

I. GENERAL

¨       NEW PROTOCOL

¨       PROGRESS REPORT

¨       NEW CORRESPONDENCE

¨       DRUG ADVERTISING

¨       ADVERSE REACTION REPORT

¨       MANUFACTURING CHANGE/ADDITION

¨       MEETING PLANNED BY

¨       PRE-NDA MEETING

¨       END OF PHASE II MEETING

¨       RESUBMISSION

¨       SAFETY/EFFICACY

¨       PAPER NDA

¨       CONTROL SUPPLEMENT

¨       RESPONSE TO DEFICIENCY LETTER

¨       FINAL PRINTED LABELING

¨       LABELING REVISION

¨       ORIGINAL NEW CORRESPONDENCE

¨       FORMULATIVE REVIEW

¨       OTHER (SPECIFY BELOW):

II. BIOMETRICS

STATISTICAL EVALUATION BRANCH

STATISTICAL APPLICATION BRANCH

¨       TYPE A OR B NDA REVIEW

¨       END OF PHASE II MEETING

¨       CONTROLLED STUDIES

¨       PROTOCOL REVIEW

¨      ADVERSE REACTION REPORT

¨      OTHER (SPECIFY BELOW):

¨      CHEMISTRY REVIEW

¨      PHARMACOLOGY REVIEW

¨      BIOPHARMACEUTICS

¨      OTHER (SPECIFY BELOW):

III. BIOPHARMACEUTICS

¨       DISSOLUTION

¨       BIOAVAILABILITY STUDIES

¨       PHASE IV STUDIES

Ì       DEFICIENCY LETTER RESPONSE

¨       PROTOCOL-BIOPHARMACEUTICS

¨       IN-VIVO WAIVER REQUEST

IV. DRUG EXPERIENCE

¨       PHASE IV SURVEILLANCE/EPIDEMIOLOGY PROTOCOL

¨       DRUG USE e.g. POPULATION EXPOSURE, ASSOCIATED DIAGNOSES

¨       CASE REPORTS OF SPECIFIC REACTIONS (List below)

¨       COMPARATIVE RISK ASSESSMENT ON GENERIC DRUG GROUP

¨      REVIEW OF MARKETING EXPERIENCE, DRUG USE AND SAFETY

¨       SUMMARY OF ADVERSE EXPERIENCE

¨      POISON RISK ANALYSIS

V. SCIENTIFIC INVESTIGATIONS

¨       CLINICAL

¨       PRECLINICAL

COMMENTS/SPECIAL INSTRUCTIONS: 

Consult is preceded by a hard copy of the firm’s resubmission received and delivered by the DDR on July 8, 2003.  Note that this is most likely to a be a two month response, due on September 3.  We are meeting on July 15 at 10:00 a.m. to determine the completeness of response and the resubmission class.

The EDR version was posted on July 7, 2003, and was immediately forwarded to the review team on that date.  A copy of the link is below.

\\CDSESUB1\N21515\N_000\2003-07-03

SIGNATURE OF REQUESTER See DFS

METHOD OF DELIVERY (CHECK ONE)

Ì      MAIL                    HAND

SIGNATURE OF RECEIVER

SIGNATURE OF DELIVERER