Victrelis

NDA 202258, held by Merck Sharp Dohme. Boceprevir.

As of Nov 14, 2026, NDA 202258 (Victrelis), held by Merck Sharp Dohme, was first approved by FDA on May 13, 2011, with 15 approved supplements and 0 published complete response letters.

First approved: May 13, 2011
Review: Priority
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Apr 9, 2014	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 27, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 13, 2013	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 13, 2011	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Victrelis200MG · capsule;oral	Boceprevir	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Jan 30, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Jul 28, 2014	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 9, 2014	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 24, 2014	Supplement 14Labeling · Standard review	Approved	Letter Label
Feb 7, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 17, 2014	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 18, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 22, 2013	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 27, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 15, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Feb 13, 2013	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 21, 2012	Supplement 6Labeling · Standard review	Approved	Label Letter
Nov 2, 2012	Supplement 5Labeling · Standard review	Approved	Label Letter
Jul 30, 2012	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 20, 2012	Supplement 2Labeling · Standard review	Approved	Letter Label
May 13, 2011	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202258
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

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