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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:  04/22/2019
 
Trade Name:  Corlanor Oral Solution
 
Generic Name or Proper Name (*):  ivabradine
 
Indications Studied:  Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients age 6 months to less than 18 years old and are supported by pharmacokinetic and pharmacodynamic trials and evidence from adequate and well-controlled trials of Corlanor in adult patients. *The pediatric study included 116 patients in the following age groups: 17 patients in the 6 months to less than 12 months age group, 36 patients in the 1 year to less than 3 years age group, and 63 patients in the 3 years to less than 18 years age group. *Safety and efficacy have not been established in patients less than 6 months of age. *Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor. *Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor, respectively. *Phosphenes were observed in pediatric patients treated with Corlanor. *Information on dosing, adverse reactions, PK parameters and clinical trial. *New dosage form.
 
Product Labeling:  [INVALID]  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Amgen
 
Pediatric Exclusivity Granted Date:  03/30/2019
 
NNPS:  FALSE
 
Therapeutic Category:  Heart failure
 
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