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FDA Issues Approvable Letter for Ribavirin Capsules

SPRING VALLEY, N.Y., Feb. 23 /PRNewswire-FirstCall/ -- Par Pharmaceutical, Inc., the principal subsidiary of Pharmaceutical Resources, Inc. , today announced that its marketing partner, Three Rivers Pharmaceuticals, has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for ribavirin 200 mg capsules. The FDA has completed its review of Three Rivers' Abbreviated New Drug Application (ANDA) for ribavirin and has concluded that the application is approvable. Final approval is subject only to resolution of certain regulatory issues involving final product labeling.

Ribavirin, a synthetic nucleoside analogue with antiviral activity, is indicated for the treatment of hepatitis C, a chronic condition suffered by approximately 4 million Americans. Ribavirin is currently marketed by Schering-Plough Corporation under the brand name Rebetol®. The U.S. market for ribavirin products is approximately $600 million annually.

Three Rivers filed an ANDA containing a paragraph IV certification with the FDA in July 2001 seeking marketing clearance for its generic version of Rebetol®. Under the terms of its agreement with Three Rivers, Par has exclusive rights to market Three Rivers' ribavirin product.

On July 16, 2003, the United States District Court for the Central District of California granted summary judgment of non-infringement regarding ribavirin to Three Rivers. The district court determined that the Three Rivers' product does not infringe any of three patents asserted by ICN Pharmaceuticals in the litigation. Earlier, Three Rivers reached a settlement of its patent litigation with Schering-Plough, so this court decision resolved the remaining patent barriers to FDA approval of Three Rivers' ANDA.

Source: Pharmaceutical Resources, Inc.

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