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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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