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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Medicis
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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