Cranberry Township, PA
February 23, 2004
Three Rivers Pharmaceuticals announced today that it received an “Approvable” letter from the U.S. Food and Drug Administration (FDA) for Ribasphere™ (Ribavirin, USP) Capsules 200mg.
Ribavirin is a synthetic nucleoside analog with antiviral activity used in combination therapy for the treatment of hepatitis C.
This letter indicates to Three Rivers Pharmaceuticals that the FDA has completed its review of the Abbreviated New Drug Application submitted by Three Rivers Pharmaceuticals in July, 2001, and that the application satisfies all FDA pre-market approval requirements except for resolution by the FDA of certain labeling issues. In July, 2003 the United States District Court for the Central District of California granted summary judgment in favor of Three Rivers Pharmaceuticals ruling it was not infringing certain patents held by ICN Pharmaceuticals, Inc. and Ribapharm, Inc. involving ribavirin.
“We will work diligently with the FDA to resolve any remaining labeling issues in order to gain final approval for Ribasphere™ (Ribavirin, USP) Capsules 200mg, said Donald J. Kerrish, RPh., Three Rivers Pharmaceuticals President and Chief Executive Officer. “With over 2.4 million patients infected with Hepatitis C in the United States, we are encouraged that there will soon be an affordable alternative available for patients. Three Rivers Pharmaceuticals will be working closely in this process with its marketing partner PAR Pharmaceutical, Inc.
Three Rivers Pharmaceuticals is a privately-owned generic drug manufacturing company located in Cranberry Township, Pennsylvania, just north of Pittsburgh.
For more information about Three Rivers Pharmaceuticals, visit 3riverspharma.com