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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:  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  Opens a new window
 
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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