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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:  09/13/2019
 
Trade Name:  Teflaro Injection
 
Generic Name or Proper Name (*):  ceftaroline fosamil
 
Indications Studied:  Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) to include pediatric patients from birth to less than 2 months
 
Label Changes Summary:  *Safety and effectiveness in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age); previously approved down to 2 months. *Use of Teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. *Safety and effectiveness in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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