Signifor Lar Kit

Treats acromegaly. NDA 203255, held by Recordati Rare. Pasireotide Pamoate.

As of Nov 14, 2026, NDA 203255 (Signifor Lar Kit), held by Recordati Rare, was first approved by FDA on Dec 15, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2014
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. 1.1 Acromegaly SIGNIFOR LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. 1.2 Cushing's Disease SIGNIFOR LAR is indicated for the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Jun 29, 2018	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 15, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

5 strengths and forms


Signifor Lar KitEQ 20MG BASE/VIAL · for suspension;intramuscular	Pasireotide Pamoate	RxReference drug
Signifor Lar KitEQ 40MG BASE/VIAL · for suspension;intramuscular	Pasireotide Pamoate	RxReference drug
Signifor Lar KitEQ 60MG BASE/VIAL · for suspension;intramuscular	Pasireotide Pamoate	RxReference drug
Signifor Lar KitEQ 10MG BASE/VIAL · for suspension;intramuscular	Pasireotide Pamoate	RxReference drug
Signifor Lar KitEQ 30MG BASE/VIAL · for suspension;intramuscular	Pasireotide Pamoate	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Jul 11, 2024	Supplement 11Labeling · Standard review	Approved	Letter Label
Jul 9, 2020	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 11, 2019	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 29, 2019	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 29, 2018	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 9, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
Jul 8, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 15, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 203255
Drugs@FDA: Overview at FDA
Company: Recordati Rare Diseases

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