Somatuline Depot

NDA 22074, held by Ipsen Pharma. Lanreotide Acetate.

As of Nov 14, 2026, NDA 22074 (Somatuline Depot), held by Ipsen Pharma, was first approved by FDA on Aug 30, 2007, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 30, 2007
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Sep 15, 2017	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 16, 2014	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Mar 4, 2011	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 30, 2007	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Somatuline DepotEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) · solution;subcutaneous	Lanreotide Acetate	RxReference drug
Somatuline DepotEQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) · solution;subcutaneous	Lanreotide Acetate	RxReference drug
Somatuline DepotEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) · solution;subcutaneous	Lanreotide Acetate	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Jul 11, 2024	Supplement 32Labeling · Standard review	Approved	Letter Label
Feb 24, 2023	Supplement 26Manufacturing · Standard review	Approved	Label Letter
Jun 14, 2019	Supplement 21Manufacturing	Approved	Letter Label
Apr 11, 2019	Supplement 24Labeling	Approved	Label Letter
Dec 12, 2018	Supplement 22Labeling · Standard review	Approved	Label Letter
Feb 22, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 23, 2017	Supplement 20Manufacturing	Approved	None posted
Sep 15, 2017	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 11, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 2, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 1, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 1, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 22, 2014	Supplement 10Labeling · Standard review	Approved	Label Letter
Dec 16, 2014	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 28, 2014	Supplement 4Manufacturing · Standard review	Approved	Review Label
Oct 23, 2014	Supplement 9Manufacturing · Standard review	Approved	Review
Feb 21, 2014	Supplement 7Manufacturing · Standard review	Approved	Review
Nov 27, 2013	Supplement 6Labeling · Standard review	Approved	Letter Label
Mar 4, 2011	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 30, 2007	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 22074
Drugs@FDA: Overview at FDA
Company: Ipsen Pharma

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