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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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