Arranon

Treats T-cell acute lymphoblastic leukemia (T-ALL) and … lymphoblastic lymphoma (T-LBL). NDA 21877, held by Sandoz. Nelarabine.

As of Nov 14, 2026, NDA 21877 (Arranon), held by Sandoz, was first approved by FDA on Oct 28, 2005, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2005
Review: Priority
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jul 31, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 28, 2005	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Arranon250MG/50ML (5MG/ML) · injectable;intravenous	Nelarabine	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Mar 11, 2025	Supplement 14Labeling · Standard review	Approved	Label Letter
Aug 2, 2019	Supplement 12Manufacturing · Standard review	Approved	Letter Label
Jul 31, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 29, 2018	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 3, 2018	Supplement 8Labeling · Standard review	Approved	Letter
Jun 4, 2015	Supplement 6Manufacturing · Priority review	Approved	None posted
Feb 6, 2012	Supplement 5Labeling · Standard review	Approved	Letter Label
Dec 15, 2009	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 15, 2009	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 28, 2005	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21877
Drugs@FDA: Overview at FDA
Company: Sandoz

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