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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:  07/01/2008
 
Trade Name:  Flovent HFA
 
Generic Name or Proper Name (*):  fluticasone propionate
 
Indications Studied:  Asthma in < 4 years
 
Label Changes Summary:  * Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. * Clinical studies were conducted in children with asthma 6 months to less than 4 years * Information added to Pediatric Use
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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