Schering Plough Rebetol pediatric approval
Executive Summary
Schering Plough's Rebetol (ribavirin) capsules and oral solution approved July 30 for treatment of pediatric hepatitis C. Rebetol is indicated for use in combination with Schering's Intron A (interferon) "for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with alpha interferon," Schering says. Company has plans for Rebetol pediatric study in combination with PEG-Intron. FDA grants orphan drug status to pediatric use...