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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:  12/28/2001
Trade Name:  Rebetron; Rebetrol
Generic Name or Proper Name (*):  ribavirin/intron a; ribavirin
Indications Studied:  Chronic hepatitis C
Label Changes Summary:  * Labeling for 3 years to 16 years * There are no safety and efficacy data on treatment for longer than 48 weeks in pediatric patients * Pharmacokinetic information on patients 5 to 16 years with chronic hepatitis C virus infection * Increased incidence of suicidal ideation or attempts (2.4% versus 1%) among pediatric patients compared to adult patients * Decrease in rate of linear growth (mean percentile assignment decrease of 9%) and in rate of weight gain (mean percentile assignment decrease of 13%) during 48 weeks of treatment; a general reversal was noted during the 24 week post treatment period * Patients with viral genotype 1, had a lower response rate to combination therapy compared to patients with genotype non-1, 36% versus 81% * In general, the adverse event profile in the pediatric population was similar to that observed in adults * New oral suspension developed
Product Labeling:  Labeling  Opens a new window
Sponsor:  Schering
Pediatric Exclusivity Granted Date:  05/09/2001
Therapeutic Category:  Antiviral