Treanda

NDA 22249, held by Cephalon. Bendamustine Hydrochloride.

As of Nov 13, 2026, NDA 22249 (Treanda), held by Cephalon, was first approved by FDA on Mar 20, 2008, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2008
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TREANDA is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. 1.1 Chronic Lymphocytic Leukemia (CLL) TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 20, 2008	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

4 strengths and forms

Product	Active ingredient	Marketing
Treanda100MG/VIAL · powder;intravenous	Bendamustine Hydrochloride	RxReference drug
Treanda25MG/VIAL · powder;intravenous	Bendamustine Hydrochloride	RxReference drug
Treanda45MG/0.5ML (90MG/ML) · solution;intravenous	Bendamustine Hydrochloride	DiscontinuedReference drug
Treanda180MG/2ML (90MG/ML) · solution;intravenous	Bendamustine Hydrochloride	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 25, 2022	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 10, 2021	Supplement 25Labeling · Standard review	Approved	Letter Label
Nov 21, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
Dec 15, 2017	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 18, 2016	Supplement 22Labeling · Standard review	Approved	Letter Label
Nov 5, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 2, 2015	Supplement 21Labeling · Standard review	Approved	Review Letter Label
Jul 8, 2015	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 10, 2015	Supplement 19Labeling · Standard review	Approved	Review Letter Label
Mar 27, 2014	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 13, 2013	Supplement 15Manufacturing · Priority review	Approved	Review Label
Aug 28, 2013	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 26, 2012	Supplement 12Labeling · Standard review	Approved	Letter Label Pediatric Amendment 2 Pediatric Amendment 1
Dec 21, 2010	Supplement 6Labeling	Approved	Letter Label
Feb 26, 2010	Supplement 5Labeling	Approved	Letter Label
May 1, 2009	Supplement 1Manufacturing	Approved	Review Label Letter
Apr 22, 2009	Supplement 2Labeling · Standard review	Approved	Label Letter
Mar 20, 2008	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22249
Drugs@FDA: Overview at FDA
Company: Cephalon

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