NDA 21-515
Page 3
Attachment A
(This attachment is to be
completed for those applications with multiple indications only.)
Indication #2:
____________________
Is there a full wavier
for this indication (check one)?
q
Yes: Please proceed to Section A.
q
No: Please
check all that apply: ___Partial Waiver ___Deferred ___Completed
NOTE: More than
one may apply
Please
proceed to Section B, Section C, and/or Section D and complete as necessary.
|
Section
A: Fully Waived Studies |
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
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 in 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
Other: _____________________
If
studies are deferred, proceed to Section C.
If studies are completed, proceed to Section D. Otherwise, this Pediatric Page is complete
and should be entered into DFS.
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