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U.S. Department of Health and Human Services

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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Eli Lilly
 
NNPS:  FALSE
 
Therapeutic Category:  Peripheral Vasodilator
 
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