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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:  08/12/2019
Trade Name:  Dulera Inhalation Aerosol
Generic Name or Proper Name (*):  formoterol fumarate/mometasone furoate
Indications Studied:  Asthma in pediatric patients 5 -11 years
Label Changes Summary:  *Expanded indication to pediatric patients 5 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and effectiveness have not been established in children younger than 5 years. *Safety profile for pediatric patients is similar to that observed in patients aged 12 years and older. *New Dulera 50 mcg/5 mcg metered dose inhaler. *Information on dosing, PK parameters, adverse reactions, lab abnormalities, and clinical trial. *Postmarketing study.
BPCA(B) and PREA(P):  B,P
Sponsor:  Merck Sharp & Dohme
Pediatric Exclusivity Granted Date:  06/24/2019
Therapeutic Category:  Antiasthmatic