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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:  04/25/2014
 
Trade Name:  Asmanex HFA
 
Generic Name or Proper Name (*):  mometasone furoate
 
Indications Studied:  Maintenance treatment of asthma as prophylactic therapy
 
Label Changes Summary:  Approved for use in adults and pediatric patients 12 years and older Safety and efficacy hav not been established in children less than 12 years The growth of pediatric patients receiving orally inhaled corticosteroids should be monitored routinely To minimize the systemic effects of orally inhaled corticosteroids each patient should be titrated to his/her lowest effective dose Information on dosing, adverse reactions, and clinical trials New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
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