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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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