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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:  11/25/2014
 
Trade Name:  Priftin
 
Generic Name or Proper Name (*):  rifapentine
 
Indications Studied:  Treatment of latent tuberculosis infection (LTBI) caused by Mycobacterium tuberculosis in combination with isoniazid (INH)
 
Label Changes Summary:  *At the time of approval, the safety and effectiveness of PRIFTIN in combination with isoniazid (INH) once-weekly regimen for the treatment of LTBI was established *A study of 742 pediatric patients (2-17 years of age) compared the effectiveness of 12 weekly doses of PRIFTIN in combination with INH (3RPT/INH arm) administered by directly observed therapy to 9 months of self-administered daily INH (9INH arm) *The safety profile in children in clinical studies was similar to that observed in adults *Weight based dosage recommendations for treatment of LTBI
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Sanofi Aventis
 
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