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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
05/18/2007
Trade Name:
Locoid Lotion 0.1%
Generic Name or Proper Name (*):
hydrocortisone butyrate
Indications Studied:
Treatment of mild to moderate atopic dermatitis in children 3 months of age and older
Label Changes Summary:
Effectiveness established in one study of 284 patients from 3 months to 18 years of age Information provided on HPA axis suppression from one safety study with Locoid Lotion of 84 pediatric patients from 3 months to 18 years of age with moderate to severe atopic dermatitis affecting at least 25% of body surface area Studies waived in children < 3 months of age New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Ferndale Labs
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
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