Linzess

For constipation (IBS-C). NDA 202811, held by Abbvie. Linaclotide.

As of Nov 13, 2026, NDA 202811 (Linzess), held by Abbvie, was first approved by FDA on Aug 30, 2012, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 30, 2012
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LINZESS is indicated for the treatment of:

irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older
chronic idiopathic constipation (CIC) in adults
functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. Chronic idiopathic constipation (CIC) in adults. Functional constipation (FC) in pediatric patients 2 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
May 21, 2026	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 4, 2025	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Label Medication Guide Letter
Jun 12, 2023	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Sep 22, 2020	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 25, 2017	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Aug 30, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

3 strengths and forms

Product	Active ingredient	Marketing
Linzess145MCG · capsule;oral	Linaclotide	RxReference drug
Linzess290MCG · capsule;oral	Linaclotide	RxReference drug
Linzess72MCG · capsule;oral	Linaclotide	RxReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 21, 2026	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 4, 2025	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Label Medication Guide Letter
Jun 12, 2023	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Aug 24, 2021	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 12, 2021	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 22, 2020	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 8, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 25, 2017	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jan 6, 2017	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 31, 2016	Supplement 11Labeling · Standard review	Approved	Letter Label
May 18, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 6, 2016	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 23, 2015	Supplement 9Labeling · Standard review	Approved	Label Letter
Jan 5, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 11, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 9, 2014	Supplement 4Labeling · Standard review	Approved	Label Letter
Jul 1, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 8, 2013	Supplement 3Labeling · Standard review	Approved	Letter Label
Aug 30, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: LINZESSSep 9, 2025

Identifiers

Application: NDA 202811
Drugs@FDA: Overview at FDA
Company: AbbVie

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