FDA Antiviral Drug Hearing

CONCLUDED

Hearing
04/27/11 – 04/28/11

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Summary

FDA Antiviral Drugs Advisory Committee will hear applications for Boceprevir and Telaprevir for treatment of Hepatitis C.

On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

Case Information
Attorneys
Witnesses
Plaintiff
Defense
Case Number
202-258, 201-917
Industry
Pharmaceutical
Practice Area
Health Law
Expert Witnesses
    Lay Witnesses

      Sessions

      Recording Disclaimer: This proceeding was recorded in full.

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