Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
-
-