DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

REQUEST FOR CONSULTATION

TO: (Division/Office): HFD-420/S. Beam, P. Guinn

FROM: HFD-120 / D. Bates

Date: June 8, 2003

IND NO.

28,686

NDA

21-515

TYPE OF DOCUMENT

trademark review

DATE OF DOCUMENT

Jan 24, 2003

NAME OF DRUG

bupropion HCl

(WELLBUTRIN XL)

PRIORITY: NDA 3S

CLASSIFICATION OF DRUG

antidepressant

DESIRED COMPLETION DATE

Action Date is 9/3/2003

need consult by 8/15/2003

this is patient info plus trademark –2^nd consult

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

Ì       OTHER (SPECIFY BELOW): TRADEMARK REVIEW, PPI REVIEW< PATIENT EDUCATION MATERIAL

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

¨       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: The attached information includes both clean and marked up copies of the firm’s reproposed package insert, including patient information (clean copy includes changes, marked up copy accentuates them).

Also included are full size color mockups of all container labeling.  A full-size mockup of the PI was not provided by the firm and has been requested for courier delivery ASAP.

Also included are the Agency AE letter with the FDA proposed draft labeling, and the reference document on which the Wellbutrin XL labeling is based, which is the Wellbutrin SR current approved labeling.  (These materials accompany hard copy of the consult form only.)

Finally, the firm’s proposed patient educational program is included

The labeling can also be found in the EDR at:

\\Cdseub1\n21515\N_000\2003-07-03\labeling

Please contact Dr. D. Bates at 301-594-5536 or via email at [email protected]v if there are any questions or further information is needed