Incivek

NDA 201917, held by Vertex Pharms. Telaprevir.

As of Nov 13, 2026, NDA 201917 (Incivek), held by Vertex Pharms, was first approved by FDA on May 23, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: May 23, 2011
Review: Priority
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Oct 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 23, 2011	Original applicationNew molecular entity, new combination · Priority review	Approved	Summary Review Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Incivek375MG · tablet;oral	Telaprevir	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Mar 25, 2014	Supplement 13Manufacturing · Priority review	Approved	None posted
Oct 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 28, 2013	Supplement 12Labeling · Standard review	Approved	Letter Label
Jul 22, 2013	Supplement 11Manufacturing · Priority review	Approved	None posted
May 8, 2013	Supplement 9Manufacturing · Priority review	Approved	None posted
Apr 25, 2013	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 14, 2012	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 27, 2012	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 22, 2012	Supplement 4Labeling · Standard review	Approved	Label Letter
Mar 22, 2012	Supplement 3Labeling · Standard review	Approved	Letter Label
May 23, 2011	Original applicationNew molecular entity, new combination · Priority review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 201917
Drugs@FDA: Overview at FDA
Company: Vertex Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters