You are here

FDA Tentatively Approves Ribasphere Tablets for the Treatment of Chronic Hepatitis C

CRANBERRY TOWNSHIP, Pa., Oct. 24 /PRNewswire/ -- Three Rivers Pharmaceuticals, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for its Ribasphere(R) (ribavirin, USP) Tablets 200 mg, 400 mg, and 600 mg in combination with interferon alfa-2a for the treatment of Hepatitis C ("HCV"). Ribavirin is a synthetic nucleoside analogue with antiviral activity currently marketed by Roche Pharmaceuticals under the brand name Copegus(R). Annual U.S. sales of the product are approximately $200 million.

"Ribasphere(R) Tablets 200 mg, 400 mg, and 600 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.

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 Pharmaceuticals (NYSE:PRX) of Spring Valley, New York.

Source: Three Rivers Pharmaceuticals

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks