Truxima

BLA 761088, held by Celltrion Inc. Rituximab-Abbs.

As of Nov 13, 2026, BLA 761088 (Truxima), held by Celltrion Inc, was first approved by FDA on Nov 28, 2018, with 8 approved supplements and 1 published complete response letter.

First approved: Nov 28, 2018
Review: Standard
Supplements approved: 8
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 18, 2019	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 18, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 23, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 23, 2019	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 28, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Review Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Feb 28, 2018	CT-P10Facility Inspections, Clinical, Product Quality	Approved

Products

2 strengths and forms

Product	Active ingredient	Marketing
Truxima100MG/10ML(10MG/ML) · injectable;injection	Rituximab-Abbs	Rx
Truxima500MG/50ML(10MG/ML) · injectable;injection	Rituximab-Abbs	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 29, 2026	Supplement 35Bioequivalence	Approved	Label Letter
Jun 9, 2025	Supplement 32Biosimilar	Approved	Label Letter
Feb 4, 2022	Supplement 18Labeling · Standard review	Approved	Letter Label Medication Guide
May 29, 2020	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 18, 2019	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 18, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 23, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 23, 2019	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 28, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Review Label

Identifiers

Application: BLA 761088
Drugs@FDA: Overview at FDA
Company: Celltrion

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