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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:
10/01/2018
Trade Name:
Seysara
Generic Name or Proper Name (*):
sarecycline
Indications Studied:
Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
Label Changes Summary:
*Safety and effectiveness have been established in adult and pediatric patients 9 years and older in two 12-week multicenter, randomized, double-blind, placebo-controlled studies in a total of 2002 patients. *Safety and effectiveness in pediatric patients below the age of 9 years has not been established. *Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration. *Information on Pk parameters, and clinical trials in adults and pediatric patients 9 and older. *New drug.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Allergan
NNPS:
FALSE
Therapeutic Category:
Antiacne, topical
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