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Background Package for NDA[removed]FDA ANTIVIRAL DRUGS ADVISORY
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Company

SVR12 Subgroup / Janssen Research and Development LLC / ITT / /

Continent

North America / Europe / South America / /

Country

United States / Australia / New Zealand / /

Event

FDA Phase / /

IndustryTerm

HCV treatment / /

MedicalCondition

disease / chronic HCV / cirrhosis / compensated liver disease / hepatitis C / HCV / Metavir Fibrosis / infection / chronic HCV infection / treatment-naïve CHC / chronic hepatitis C / fibrosis / HCV RNA / HCV genotype / /

Organization

Antiviral Products Advisory Committee / FOOD AND DRUG ADMINISTRATION / Review Division / ADVISORY COMMITTEE / FDA ANTIVIRAL DRUGS ADVISORY COMMITTEE / /

Product

GT1 / ribavirin / peginterferon / TMC48PR48 / Q80K / SVR24 / C216 / TMC435-TiDP16 / US / C208 / C206 / Victrelis® / SVR12 / C205 / SVR72 / /

Region

Asia-pacific / /

Technology

alpha / genotype / /

SocialTag