Gattex Kit

Treats Short Bowel Syndrome (SBS). NDA 203441, held by Takeda Pharms USA. Teduglutide.

As of Nov 14, 2026, NDA 203441 (Gattex Kit), held by Takeda Pharms USA, was first approved by FDA on Dec 21, 2012, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 21, 2012
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GATTEX is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


May 16, 2019	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Other Pediatric Other
Dec 18, 2018	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 26, 2014	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 21, 2012	Original applicationNew molecular entity · Standard review	Approved	REMS Review Summary Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gattex Kit5MG/VIAL · powder;subcutaneous	Teduglutide	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Aug 26, 2026	Supplement 28REMS	Approved	Letter
Sep 5, 2025	Supplement 24Labeling · Standard review	Approved	Label Medication Guide Letter
Aug 13, 2025	Supplement 23REMS	Approved	Letter
Sep 19, 2024	Supplement 22Labeling · Standard review	Approved	Label
Feb 21, 2024	Supplement 21Manufacturing	Approved	Letter Label
Jan 24, 2023	Supplement 16Labeling · Standard review	Approved	Label Letter
Feb 11, 2021	Supplement 20REMS	Approved	Letter
Jan 29, 2021	Supplement 18Labeling · Standard review	Approved	Letter Label
Jul 14, 2020	Supplement 19REMS	Approved	Letter
May 16, 2019	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Other Pediatric Other
Dec 18, 2018	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 21, 2017	Supplement 10REMS	Approved	Letter
May 27, 2016	Supplement 8REMS	Approved	Letter
Mar 30, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 5, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
May 18, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 26, 2014	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 21, 2012	Original applicationNew molecular entity · Standard review	Approved	REMS Review Summary Review Label

Identifiers

Application: NDA 203441
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

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