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Incivek FDA Approval History

FDA Approved: Yes (Discontinued) (First approved May 23, 2011)
Brand name: Incivek
Generic name: telaprevir
Dosage form: Tablets
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Hepatitis C

Marketing Status: Discontinued

Incivek (telaprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of chronic hepatitis C (CHC).

Development timeline for Incivek

May 23, 2011Approval FDA Approves Incivek (telaprevir) for People with Hepatitis C
Apr 29, 2011FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
Jan 20, 2011U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
Nov 23, 2010Vertex Completes New Drug Application for Telaprevir for Hepatitis C

Further information

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