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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:
09/11/2007
Trade Name:
Levaquin
Generic Name or Proper Name (*):
levofloxacin
Indications Studied:
Community-acquired pneumonia
Label Changes Summary:
Levofloxacin is not indicated for pediatric patients < 18 years of age In a prospective, long-term, surveillance study, levofloxacin treated children had a significantly higher incidence of musculoskeletal (MS) disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to non-fluoroquinolone-treated children Information on clinical studies, AE profile
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Ortho-McNeil
Pediatric Exclusivity Granted Date:
03/14/2007
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
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