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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:  08/22/2018
 
Trade Name:  Altreno lotion
 
Generic Name or Proper Name (*):  tretinoin
 
Indications Studied:  Topical treatment of acne vulgaris
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients age 9 years to less than 17 years based on evidence from two multicenter, randomized, double-blind, 12-week trials and an open-label pharmacokinetic study. A total of 318 pediatric subjects aged 9 to less than 17 years received Altreno in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *Information clinical trials, PK parameters, and adverse reactions. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Dow Pharmaceutical Sciences, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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