Rebetol pediatric approval
This article was originally published in Pharmaceutical Approvals Monthly
Schering-Plough gains approval July 30 for use of its hepatitis C treatment Rebetol (ribavirin) with its Intron A (interferon alfa-2b) in patients aged three years and older. A pediatric study of Rebetol in combination with Schering's pegylated interferon product, PEG-Intron,is planned. Rebetol has orphan status for pediatric hepatitis C treatment. Schering is required to conduct a Phase IV long-term follow-up pediatric study; patients who completed the 24-week study will be evaluated yearly for another five years. Generic ribavirin is expected to enter the market shortly, following FDA resolution of labeling and 180-day exclusivity issues...
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