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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:  03/31/2015
 
Trade Name:  ProAir RespiClick
 
Generic Name or Proper Name (*):  albuterol sulfate
 
Indications Studied:  Treatment or prevention of bronchospasm and prevention of exercise induced bronchospasm
 
Label Changes Summary:  *Safety and effectiveness for the treatment or prevention of bronchospasm in children 12 - 17 years and older with reversible obstructive airway disease is based on two12-week clinical trials, one long-term safety study and one -single-dose cross over study *The safety and effectiveness for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single dose crossover study *The safety profile for patients 12 to 17 years was consistent with the overall safety profile seen in adults *The safety and effectiveness in pediatric patients below the age of 12 years have not been established. 120 children with asthma ages 4 to 11 years participated in the clinical program *Information on clinical trials, and adverse reaction information in adults and children 12 years and older *New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva
 
Therapeutic Category:  Antiasthma
 
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