Olysio

NDA 205123, held by Janssen Prods. Simeprevir Sodium.

As of Nov 15, 2026, NDA 205123 (Olysio), held by Janssen Prods, was first approved by FDA on Nov 22, 2013, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 22, 2013
Review: Priority
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


May 20, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2016	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 5, 2015	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 5, 2015	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 5, 2014	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 22, 2013	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
OlysioEQ 150MG BASE · capsule;oral	Simeprevir Sodium	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Nov 9, 2017	Supplement 14Labeling · Standard review	Approved	Label Letter
May 12, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 14, 2017	Supplement 12Labeling	Approved	Label Letter
May 20, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2016	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 5, 2015	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 5, 2015	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 19, 2015	Supplement 7Manufacturing · Priority review	Approved	None posted
Apr 15, 2015	Supplement 8Labeling	Approved	Review Letter Label
Apr 10, 2015	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 3, 2015	Supplement 4Manufacturing · Priority review	Approved	None posted
Nov 5, 2014	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 5, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Dec 5, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Nov 22, 2013	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205123
Drugs@FDA: Overview at FDA
Company: Janssen Products

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