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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:  05/08/2006
 
Trade Name:  Solodyn Extended-Release Tablets
 
Generic Name or Proper Name (*):  minocycline
 
Indications Studied:  Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in children 12 years of age and older
 
Label Changes Summary:  Only used to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris Safety and effectiveness established from studies in patients 12 years of age and older Safety and effectiveness in pediatric patients below 12 years of age has not been established Studies waived in children 0-11 years of age New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Medicis
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
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