Drugs / Nelarabine
Nelarabine
also known as
506U78 · 506U · Arranon · Atriance · Attriance · GW-506U78 · Nelarabina · Nelzarabine · +3 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ARRANON | — | 2019-07-31 | fda.gov ↗ |
| Approved | EU (EMA) | Atriance | — | 2007-08-22 | europa.eu ↗ |
| Approved | US (FDA) | ARRANON | — | 2005-10-28 | fda.gov ↗ |
Trials 21
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-11-18 | Zydus Lifesciences Limited | Regulatory Zydus Cadila gets 180-day exclusivity for Nelarabine injection, announces final approval from USFDA zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Nelarabine Injection 250MG/50ML in the United States (US RLD: Arranon®). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-11-18 | Zydus Lifesciences Limited | Zydus Cadila gets 180-day exclusivity for Nelarabine injection, announces final approval from USFDA zyduslife.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nelarabine | “Mitoxantrone Nelarabine Nilotinib” NCT02551718 ↗ |
| Known as | 506U | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | 506U78 | “Nelarabine (506U78) is a soluble pro-drug of 9-beta-D-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative.” PMID 17344466 ↗ Mar 20072“Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma” NCT00406757 ↗ |
| Known as | Arranon | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Atriance | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Attriance | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | GW-506U78 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Nelarabina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | Nelzarabine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | NSC #686673 | “Compound 506U78 (NSC #686673)” NCT00004239 ↗ |
| Known as | NSC-755985 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Known as | NSC-759876 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201112 ↗ |
| Modality | Small molecule | “Nelarabine (506U78) is a soluble pro-drug of 9-beta-D-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative.” PMID 17344466 ↗ Mar 2007 |
| Route | Intravenous | “Given IV” NCT00002970 ↗ |