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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 yearsThe safety and effectiveness in children < 2 years have not been establishedInformation on clinical trials, dosing, and adverse reactionsNew drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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