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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Cerexa, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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