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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:
05/27/2016
Trade Name:
Teflaro Injection
Generic Name or Proper Name (*):
ceftaroline fosamil
Indications Studied:
Acute Bacterial Skin and Skin Structure Infections (ABSSI) and Community Acquired Bacterial Pneumonia (CABP) in pediatric patients 2 months to less than 18 years
Label Changes Summary:
*Safety and effectiveness of Teflaro in the treatment of ABSSI and CABP have been established in pediatric patients 2 months to less than 18 years. *Use of Teflaro in these age groups is supported by evidence from adequate and well-controlled studies of Teflaro in adults with additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 2 months have not been established as no data are available. *Safety findings were similar to those seen in the adult studies. *Information on dosing, PK , and adverse reactions. *Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Cerexa, Inc.
NNPS:
FALSE
Therapeutic Category:
Antibiotic
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