www.fdanews.com/articles/81935-three-rivers-announces-fda-tentative-approval-of-ribasphere
THREE RIVERS ANNOUNCES FDA TENTATIVE APPROVAL OF RIBASPHERE
October 25, 2005
Three Rivers Pharmaceuticals has reported that the FDA has granted tentative approval for its Ribasphere (ribavirin) tablets, in combination with interferon alfa-2a, for the treatment of hepatitis C. Ribavirin is a synthetic nucleoside analogue with antiviral activity currently marketed by Roche under the brand name Copegus.
Final approval is expected upon the expiration of the brand exclusivity in December 2005. Three Rivers currently manufactures and markets Amphotec/Amphocil (amphotericin B cholesteryl sulfate complex for injection) and Ribasphere (ribavirin capsules), for use in combination with interferon alfa-2b.