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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:  05/26/2010
 
Trade Name:  Nasonex
 
Generic Name or Proper Name (*):  mometasone
 
Indications Studied:  Nasal congestion associated with seasonal allergic rhinitis
 
Label Changes Summary:  * New indication in pediatric patients 2 years and older * Safety and effectiveness evaluated in 3 clinical studies in 12 years and older. Use in pediatric patients 2 - 11 years is supported by data from other pediatric clinical studies * Safety and effectiveness for any use in patients < 2 years have not been established * Information on dosing, adverse reactions, and clinical studies in 12 years and older * New indication
 
Product Labeling:  Labeling  Opens a new window
 
Sponsor:  Schering-Plough
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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