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Press Release

FDA Approves Sovaldi (Sofosbuvir) for Chronic Hepatitis C

Drug Is Third With Breakthrough Therapy Designation to Receive FDA Approval

December 6, 2013

The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

"Today's approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the

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Visit the FDA's website to find out more about their activities and publications.
 

Reader Comments:

Comment by: Gloria Irizarry (Bronx New York ) Thu., Jan. 2, 2014 at 3:43 pm EST
Hi I am hiv positive & have hep C both from a blood transfution. I am on HARRT but haven't started any treatment for hepc yet. I would like to but I didn't think I can deal with the side affects of them. I would like to know what are the side affects of this new drug. Please feel free to write to me.
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