Nulojix

Prevents organ rejection. BLA 125288, held by Bristol Myers Squibb. Belatacept.

As of Nov 13, 2026, BLA 125288 (Nulojix), held by Bristol Myers Squibb, was first approved by FDA on Jun 15, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2011
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. Limitations of Use:
Use only in patients who are EBV seropositive. (1.2, 4, 5.1)

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
Apr 13, 2018	Supplement 75Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Jun 15, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nulojix250MG · injectable; injection	Belatacept	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 28, 2021	Supplement 101Labeling · Standard review	Approved	Letter Label
Apr 13, 2018	Supplement 75Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Nov 9, 2017	Supplement 74Labeling · Standard review	Approved	Letter Label
May 9, 2017	Supplement 72REMS	Approved	Letter
Feb 2, 2017	Supplement 70Labeling · Standard review	Approved	Label Letter
Sep 30, 2014	Supplement 62Labeling · Standard review	Approved	Letter Label
Apr 15, 2014	Supplement 59Labeling · Standard review	Approved	Letter Label
Apr 8, 2013	Supplement 30Labeling · Standard review	Approved	Letter Label
Jun 15, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: BLA 125288
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters