Rebetron adds pediatric data
Executive Summary
Schering adds Rebetol pediatric use information to Rebetron (Rebetol/Intron A combination) labeling. FDA's June 8 approval letter notes there was an "oversight" in Rebetol labeling, which failed to reflect that patients under age five received only oral solution, not capsules, in pediatric trials. New labeling states oral solution is approved for ages three and older, capsules for ages five and older...
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