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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:  04/27/2007
 
Trade Name:  Veramyst
 
Generic Name or Proper Name (*):  fluticasone furoate
 
Indications Studied:  Treatment of the symptoms of seasonal and perennial allergic rhinitis
 
Label Changes Summary:  *Approved in patients 2 years and older * Controlled clinical trials included 1,224 patients 2 - 11 years and 344 adolescent patients 12 to 17 years* The safety and effectiveness in children < 2 years have not been established* Information on clinical trials, dosing, and adverse reactions*New drug
 
Product Labeling:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022051lbl.pdf  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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