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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:  05/01/2012
 
Trade Name:  Dymista
 
Generic Name or Proper Name (*):  azelastine hydrochloride and fluticasone proprionate
 
Indications Studied:  Relief of symptoms of seasonal allergic rhinitis
 
Label Changes Summary:  *Safety and effectiveness have been established in 3 clinical trials in patients 12 years and older *Safety and effectiveness in pediatric patients < 12 years have not been established *Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Dymista, should be monitored routinely *Information on dosing, adverse reactions, and clinical trials *New drug
 
Product Labeling:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s000lbl.pdf  Opens a new window
 
PREA(P):  P
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic;antiallergy
 
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