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FDA Expands Use of Schering's Hepatitis C Drugs

March 16, 2009

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While previously only approved for patients who had never taken any Hepatitis C drugs, Pegintron and Rebetol are now approved by the FDA for re-treatment.

Schering say FDA expands hepatitis drug labels

Associated Press, 03.11.09, 04:39 PM EST

The Food and Drug Administration expanded the label for Schering-Plough Corp.'s hepatitis C drugs Pegintron and Rebetol, allowing the company to market the drugs for patients who have not recovered from the disease after previous treatment.

Schering-Plough (nyse: SGP - news - people ) said Wednesday that the FDA approved the drugs for the treatment of chronic hepatitis C in patients with compensated liver disease. They were already approved for use in "treatment-naive" patients, or those who had never taken any drugs for the liver disease.

The drugs are approved for use in patients 3 and older.

The company said more than 100,000 people in the U.S. have received at least one unsuccessful treatment for hepatitis C. Sales of Pegintron totaled $914 million in 2008, and Schering-Plough reported $260 million in Rebetol revenue.

Schering-Plough on Monday accepted a buyout offer from Merck and Co. (nyse: MRK - news - people ) worth $41.1 billion.

Copyright 2009 by Associated Press

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URL for Article Source:
http://www.forbes.com/feeds/ap/2009/03/11/ap6155863.html

Posted by Editors at March 16, 2009 4:09 PM

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