Cranberry Township, PA
Three Rivers Pharmaceuticals® announces FDA Final Approval of Ribasphere® (ribavirin, USP) Tablets 600mg, 400mg and 200mg for the Treatment of Chronic Hepatitis C
Three Rivers Pharmaceuticals, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for its Ribasphere® (ribavirin, USP) Tablets 600 mg, 400 mg, and 200 mg in combination with interferon alfa-2a for the treatment of Hepatitis C (“HCV”). Three Rivers Pharmaceuticals and PAR Pharmaceuticals will be shipping product immediately.
“Ribasphere® Tablets 600 mg, 400 mg, 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 J. Kerrish, R.Ph. This new dosage strengths represent the first significant advance in the treatment of HCV since the launch of Pegasys®.
Ribavirin is a synthetic nucleoside analogue with antiviral activity currently marketed by Roche Pharmaceuticals under the brand name Copegus®. Annual U.S. sales of the product are approximately $200 million. The products will be co-marketed by Three Rivers and its marketing partner PAR Pharmaceuticals (NYSE:PRX) of Spring Valley, New York.
Three Rivers Pharmaceuticals is a closely held, privately owned company. Three Rivers Pharmaceuticals’ mission is to develop and market brand and generic prescription drugs through product acquisition and in house development.
Three Rivers currently manufactures and markets Amphotec®/Amphocil® (amphotericin B cholesteryl sulfate complex for injection) worldwide and Ribasphere® (ribavirin capsules), 200 mg for use in combination with interferon alfa-2b in the U.S.
Contact:
Paul F. Fagan, Esq., Executive Vice-President and General Counsel, Three Rivers Pharmaceuticals (800) 405-8506, pfagan@3riverspharma.com