Tentative Approval: Ribasphere for Hep C
Three Rivers Pharmaceuticals, LLC has announced that the FDA has granted tentative approval for its ribavirin (Ribasphere®) tablets in dosage strengths of 200 mg, 400 mg, and 600 mg in combination with interferon alfa-2a for the treatment of chronic hepatitis C (HCV).
Ribavirin generic is a synthetic nucleoside analogue with antiviral activity. It is marketed by Roche under the brand name Copegus tablet. Final approval is expected upon the expiration of the brand exclusivity in December 2005. The products will be co-marketed by Three Rivers and its marketing partner PAR.
