Minutes of Meeting
NDA 20-515, Wellbutrin XL
Extended Release Tablets
GSK / Biovail: Major
Depressive Disorder
Resubmission Filing Meeting
Minutes
DATE: July 15, 2003
INPUT
RECEIVED FROM: R. Katz, T. Laughren, R. Lvein, S. Yasuda,
T. Oliver, S. McLamore, D. Bates
Background: The NDA for Wellbutrin XL extended-release tablets was submitted on August 26, 2002 and was the subject of an approvable action on June 24, 2003.
Note
that the original submission predated the court set-aside of the Pediatric
Rule. The firm’s request for
¨
deferral
of pediatric studies pending approval of the adult indication and
¨
exemption
of infants and children under age 7 from pediatric studies (partial waiver)
were granted by the Division in correspondence issued October 16, 2002 (which
also predates court set-aside).
A
resubmission in response to the action letter was received on July 3,
2003. The subject meeting was scheduled
to determine the completeness and class of said resubmission.
Summary:
¨
The
resubmission was agreed to be a Class 1, 2-month response by all members
of the review team. The action due date
for this submission is therefore September 3, 2003.
¨
All
consults were forwarded prior to this meeting.
¨
Disciplines
conducting reviews of the resubmission are CMC, OCPB, and Clinical (labeling)
as well as consult reviews for the trademark, container labeling, and patient
education proposals submitted by the firm (ODS/DMETS, DSURCS).
¨
Reviews
are due to be completed by mid-August.
Post
Meeting Notes:
The firm was informed of the resubmission class and due date by telephone voice
mail immediately following the meeting. An acknowledgement letter was signed
and sent later the same day (July 15, 2003).
Please
see electronic signature page
Doris
J. Bates, Ph.D.
Regulatory
Project Manager
For
the attendees
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