Trisenox

Treats newly-diagnosed low-risk acute promyelocytic leukemia (APL). NDA 21248, held by Cephalon. Arsenic Trioxide.

As of Nov 14, 2026, NDA 21248 (Trisenox), held by Cephalon, was first approved by FDA on Sep 25, 2000, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2000
Review: Priority
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRISENOX is an arsenical indicated: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Jan 12, 2018	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 25, 2000	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

2 strengths and forms


Trisenox1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Arsenic Trioxide	DiscontinuedReference drug
Trisenox2MG/ML · injectable;injection	Arsenic Trioxide	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Oct 20, 2020	Supplement 19Labeling · Standard review	Approved	Label Letter
Jun 20, 2019	Supplement 18Labeling · Standard review	Approved	Label Letter
Jan 12, 2018	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 20, 2015	Supplement 13Labeling · Standard review	Approved	Letter Label
Jul 23, 2010	Supplement 9Labeling · Standard review	Approved	Label Letter
Jul 23, 2010	Supplement 8Labeling · Standard review	Approved	Label Letter
Jan 7, 2003	Supplement 2Manufacturing · Priority review	Approved	None posted
Jun 13, 2001	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 25, 2000	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 21248
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