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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:  11/21/2007
 
Trade Name:  Omnaris Nasal Spray
 
Generic Name or Proper Name (*):  ciclesonide
 
Indications Studied:  Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age
 
Label Changes Summary:  * Indication extended down to 6 years of age * Pediatric dosing information provided * Two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo * Efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group. * Waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Nycomed US Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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