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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:  Labeling  Opens a new window
 
PREA(P):  P
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic;antiallergy
 
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