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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
02/15/2018
Trade Name:
Cialis
Generic Name or Proper Name (*):
tadalafil
Indications Studied:
Duchenne muscular dystrophy
Label Changes Summary:
*Not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. *A randomized, double-blind, placebo-controlled trial in pediatric patients 7 to 14 years with Duchenne muscular dystrophy failed to demonstrate any benefit of treatment on a range of assessments of muscle strength and performance.
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Eli Lilly
NNPS:
FALSE
Therapeutic Category:
Peripheral Vasodilator
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