FDA Antiviral Drug Hearing
CONCLUDED
Hearing
04/27/11 – 04/28/11
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.
- Plaintiff
- Defense
- Jurisdiction
- Food and Drug Administration
- Court
- FDA White Oak Campus
- Case Number
- 202-258, 201-917
- Industry
- Pharmaceutical
- Practice Area
- Health Law
- Expert Witnesses
- Lay Witnesses
Sessions
AM Session
Other
4 Chapters
| Description | Attorney | Witness | Presence | |||
|---|---|---|---|---|---|---|
 | 00:00:00 | General Case Activities | ||||
| 02:16:42 | Break | ||||
| 02:33:27 | General Case Activities | ||||
| 04:05:09 | End of Session |
PM Session
Other
4 Chapters
PM Session
Other
4 Chapters
AM Session
Other
4 Chapters
Recording Disclaimer: This proceeding was recorded in full.