Par Pharmaceutical Companies, marketing partner, Three Rivers Pharmaceuticals, has received final approval by the US Food and Drug Administration for its abbreviated new drug application (ANDA) for ribavirin 200 mg, 400 mg and 600 mg tablets.

According to a company release, ribavirin, a synthetic nucleoside analogue with antiviral activity, is used in combination with peginterferon alfa-2a for the treatment of hepatitis C. Ribavirin tablets are currently marketed by Roche Pharmaceuticals under the brand name Copegus. Annual US sales of the product are approximately $200 million.

Under the terms of its agreement with Three Rivers, Par will co-market Three Rivers' ribavirin tablets and the companies will split profits from the sales of the product. Par will begin shipping ribavirin 200 mg tablets immediately.

Par Pharmaceutical Companies Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc.