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Par, Three Rivers and Teva say FDA approved ribavirin, generic of Roche's Copegus to treat hepatitis C
By E. Janene Geiss
Philadelphia, Dec. 5 - Par Pharmaceutical Cos., Inc. said Monday that its marketing partner, Three Rivers Pharmaceuticals, has received final approval by the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ribavirin 200 mg, 400 mg and 600 mg tablets.
In a separate announcement, Israel-based Teva Pharmaceuticals said Monday that its Abbreviated New Drug Application for ribavirin tablets 200 mg received approval from the FDA.
Ribavirin, a synthetic nucleoside analogue with antiviral activity, is used in combination with peginterferon alfa-2a for the treatment of hepatitis C.
It is the generic version of Copegus, the brand name currently marketed by Roche Pharmaceuticals.
Annual U.S. sales of the product are about $200 million, officials said.
Under the terms of its agreement with Three Rivers, Par will co-market Three Rivers' ribavirin tablets and the companies will split profits from sales of the product, according to a company news release.
"Ribasphere tablets 600 mg, 400 mg and 200 mg provide the patient and physician an opportunity to significantly reduce the number of tablets a patient has to take each day. Three Rivers believes that this has the potential to lead to better patient compliance and improved patient outcomes," Donald J. Kerrish, president and chief executive officer of Cranberry Township, Pa.-based Three Rivers, said in the release.
Par, based in Spring Valley, N.Y., said it will begin shipping ribavirin 200 mg tablets immediately.
Meanwhile, Teva officials said that shipment will begin immediately.
Teva develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.
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