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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:
09/01/2017
Trade Name:
Cubicin Injection
Generic Name or Proper Name (*):
daptomycin
Indications Studied:
Staphylococcus aureus bacteremia
Label Changes Summary:
*Safety and effectiveness in the treatment staphylococcus. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. *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 from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections. *Safety and effectiveness in pediatric patients below the age of one year have not been established. *Cubicin has not been studied in pediatric patients with other bacterial infections. *Information on dosing, PK parameters, adverse reactions, and clinical trial.
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
Cubist Pharmaceuticals, Inc.
NNPS:
FALSE
Therapeutic Category:
Antibiotic
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