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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:  03/29/2017
 
Trade Name:  Cubicin Injection
 
Generic Name or Proper Name (*):  daptomycin
 
Indications Studied:  Complicated skin and skin structure infections (cSSSI) in pediatric patients 1 to 17 years of age
 
Label Changes Summary:  *Safety and effectiveness in the treatment of cSSSI has been established in the age groups 1 to 17 years. Use in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and data from a safety, efficacy and PK study in pediatric patients 1 to 17 years of age with cSSSI. * Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Cubicin in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems observed in neonatal dogs. * Not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. * The safety profile in pediatric patients was similar to that observed in adult patients. * Information on dosing, administration, adverse reactions, PK, and clinical trial. * Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Cubist Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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