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New Pediatric Labeling Information Database - Detail

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New Pediatric Labeling Information Database
Detail

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Pediatric Labeling Date:	08/12/2019

Trade Name:	Asmanex HFA

*Generic Name or Proper Name ():**	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 Asmanex HFA 50 mcg/5 mcg metered dose inhaler. Information on dosing, adverse reactions, clinical trial. Postmarketing study.

PREA(P):	P

Sponsor:	Merck Sharp & Dohme

NNPS:	FALSE

Therapeutic Category:	Antiasthmatic

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