Teva Pharmaceutical Industries has announced that the U.S. Food and Drug Administration has granted final approval for the Company’s ANDA for Ribavirin Capsules, 200 mg. Shipment of this product is expected to begin immediately.
Ribavirin Capsules are the AB-rated generic equivalent of Schering’s Rebetol® Capsules. Teva’s product is indicated for use with interferon alpha-2b recombinant injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy.
Total annual sales of the product, including brand and generic sales, are approximately $377 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva’s sales are in North America and Europe.