Lutathera

Treats somatostatin receptor-positive … hindgut neuroendocrine tumors. NDA 208700, held by Aaa USA Inc. Lutetium Lu-177 Dotatate.

As of Nov 13, 2026, NDA 208700 (Lutathera), held by Aaa USA Inc, was first approved by FDA on Jan 26, 2018, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2018
Review: Priority
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Apr 23, 2024	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Label
Jun 13, 2022	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 29, 2020	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label
May 28, 2020	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter
Jan 26, 2018	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lutathera10mCi/ML · solution;intravenous	Lutetium Lu-177 Dotatate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Nov 26, 2024	Supplement 32Labeling · Standard review	Approved	Label Letter
Apr 23, 2024	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Label
Mar 7, 2023	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 13, 2022	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 13, 2022	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 6, 2022	Supplement 20Labeling · Standard review	Approved	Letter
May 29, 2020	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label
May 28, 2020	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter
Jan 26, 2018	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 208700
Drugs@FDA: Overview at FDA
Company: AAA USA Inc

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