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FDA approves Three Rivers’ generic hepatitis C drug

The FDA has granted final approval for Three Rivers Pharmaceuticals' generic Ribasphere 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 Pharmaceuticals under the brand name Copegus. Annual US sales of the product are approximately $200 million.

“Ribasphere Tablets 600mg, 400mg, and 200 mg provide the patient and physician an opportunity to significantly reduce the number of tablets a patient has to take each day. Three Rivers believes that this has the potential to lead to better patient compliance and improved patient outcomes,” said Three Rivers president and CEO Donald Kerrish.

The products will be co-marketed by Three Rivers and its marketing partner Par Pharmaceuticals.