Esbriet

As of Nov 14, 2026, NDA 22535 (Esbriet), held by Legacy, was first approved by FDA on Oct 15, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2014
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 15, 2014	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Esbriet267MG · capsule;oral	Pirfenidone	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Feb 24, 2023	Supplement 16Labeling · Standard review	Approved	Label Letter
Feb 11, 2022	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 31, 2019	Supplement 12Labeling · Standard review	Approved	Label Letter
Jan 11, 2017	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 11, 2017	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 8, 2016	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 24, 2015	Supplement 1Manufacturing · Priority review	Approved	Label
Oct 15, 2014	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22535
Drugs@FDA: Overview at FDA
Company: LEGACY

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