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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:  10/18/2019
 
Trade Name:  Amzeeq
 
Generic Name or Proper Name (*):  minocycline
 
Indications Studied:  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 pediatric patients 9 years and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. *Use for this indication is supported by three adequate and well-controlled 12-week trials in patients 9 years and older. A total of 686 patients 9 years and older received Amzeeq in these clinical trials. *Safety and effectiveness for this indication have not been established in pediatric patients less than 9 years. *The use of oral tetracycline drugs during tooth development below the age of 8 years may cause permanent discoloration of the teeth and inhibition of bone growth. *Information on PK parameters and clinical trials. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Foamix Pharmaceuticals Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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