Three Rivers Pharmaceuticals Announces FDA Tentative Approval of Ribasphere(R) (Ribavirin, USP) Tablets for the Treatment of Chronic Hepatitis C
Posted on: Monday, 24 October 2005, 09:01 CDT
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 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(R)/Amphocil(R) (amphotericin B cholesteryl sulfate complex for injection) worldwide and Ribasphere(R) (ribavirin capsules), 200 mg for use in combination with interferon alfa-2b in the U.S.
Three Rivers Pharmaceuticals
CONTACT: Angelia Impellicceiri of Three Rivers Pharmaceuticals,+1-724-778-6100, or aimpellicceiri@3riverspharma.com
Source: PRNewswire
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