The US Food and Drug Administration has granted Teva Pharmaceuticals a final approval for its ANDA for ribavirin tablets, 200 mg. Shipment of this product will begin immediately.
Teva's ribavirin tablets are the AB-rated generic equivalent of Roche's Copegus tablets, a product indicated for use in combination with peginterferon alfa-2a for treatment of adults with chronic hepatitis C virus who have compensated liver disease and have not been previously treated with interferon alpha, informs a company release.
The brand product has annual sales of approximately $203 million.
Teva Pharmaceutical Industries Ltd. is among the top 20 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.