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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:  01/10/2008
 
Trade Name:  Alvesco Inhalation Aerosol, 80 mcg & 160 mcg
 
Generic Name or Proper Name (*):  ciclesonide
 
Indications Studied:  Treatment of asthma in patients 12 years of age and older.
 
Label Changes Summary:  * Not indicated for children under the age of 12 years * Five clinical studies evaluated safety in children 12 years of age and older * Safety and effectiveness have not been established in children under 12 years of age * Waiver of studies in children 0 to less than 6 months of age due to too few patients with the disease * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Nycomed US Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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