MEMORANDUM DEPARTMENT
OF HEALTH AND HUMAN SERVICES
PUBLIC
HEALTH SERVICE
FOOD
AND DRUG ADMINISTRATION
CENTER
FOR DRUG EVALUATION AND RESEARCH
DATE: August
21, 2003
FROM: Thomas
P. Laughren, M.D.
Team
Leader, Psychiatric Drug Products
Division
of Neuropharmacological Drug Products
SUBJECT: Recommendation for approval action for NDA 21-515
for Wellbutrin XL (an extended release formulation of bupropion), for major
depressive disorder
TO: File, NDA 21-515
[Note: This memo should be filed with
the 7-3-03 response to our 6-24-03 approvable letter.]
Background
See 6-6-03 memo to file for
background information leading up to the approvable action.
In our 6-24-03 approvable
letter, we requested the following:
-Risk management plan regarding the name Wellbutrin
XL
-Mock-up of container labels to facilitate final
evaluation of name and labels
-Full response to CMC deficiencies
-Adoption of proposed dissolution specifications
-Literature search regarding potential drug
interactions
-Safety update, including literature update
-Response to our proposed labeling
Risk management plan regarding the name Wellbutrin XL
-We expressed concern about the potential for
medication errors, given the 2 different sustained release formulations of
Wellbutrin (SR and XL), and for this reason, asked for a risk management plan
to educate health care providers and patients.
-The sponsor proposed an educations program as
requested. These materials were
reviewed by Jeanine Best from ODS/DSRCS, Charles Hoppes from ODS/DMETS, and
DDMAC.
-Jeanine Best and DSRCS supervisory staff found the
educational materials acceptable, however, had a few minor recommendations for
the PPI and some advice for the sponsor to be implemented postapproval; we will
convey these comments in the approval letter.
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