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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:  03/23/2016
 
Trade Name:  Cinqair
 
Generic Name or Proper Name (*):  reslizumab
 
Indications Studied:  Asthma in patients 12 to 17 years
 
Label Changes Summary:  * The safety and effectiveness in pediatric patients have not been established. * CINQAIR was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week exacerbation studies and one 16-week lung function study. In these studies, the asthma exacerbation rate was higher in adolescent patients treated with CINQAIR than placebo. * Information on clinical trials. * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva Respiratory, LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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