PEDIATRIC PAGE
(Complete for all APPROVED
original applications and efficacy supplements)
D/BLA
# : 21-515 Supplement Type (e.g. SE5): __________ Supplement Number:
Stamp
Date: August 26, 2002 Action Date: August 28, 2003
HFD 120 Trade
and generic names/dosage form: Wellbutrin
XL (bupropion hydrochloride extended-release Tablets
Applicant:
GlaxoSmithKline Therapeutic Class: Antidepressant of
the aminoketone class
Indication(s)
previously approved: Major Depressive Disorder
Each approved indication must have pediatric studies: Completed, Deferred, and/or Waived.
Number
of indications for this application(s): 1_
Indication
#1: Major Depressive Disorder______________
Is there a full waiver for this indication (check one)?
Yes: Please proceed to Section
A.
X No: Please check all that apply: __ Partial Waiver _X_ Deferred ___Completed
|
Section
A: Fully Waived Studies |
Reason
(s) for full wavier
q Products in this class for
this indication have been studied/labeled for pediatric population
q Disease/condition does not
exist in children
q Too few children with disease to study
q There are safety concerns
q Other: _____________________________________________
If studies are fully waived, then pediatric information
is complete for this indication. If
there is another indication, please see Attachment A. Otherwise this Pediatric Page is complete and should be entered
into DFS.
|
Section
B: Partially Waived Studies |
Age/weight
range being partially waived:
Min
_____ kg _____ mo. _____ yr. _____ Tanner
Stage _____
Min
_____ kg _____ mo. _____ yr. _____ Tanner
Stage _____
Reason(s)
for partial waiver:
q Products in this class for
this indication have been studied/labeled for pediatric population
q Disease/condition does not
exist in children
q Too few children with
disease to study
q There are safety concerns
q Adult studies ready for
approval
q Formulation needed
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