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Details for Generic Name: nelarabine

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Nelarabine is the generic ingredient in one branded drug marketed by Smithkline Beecham and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for nelarabine. One supplier is listed for this compound.

Summary for Generic Name: nelarabine

Drug Master File Entries: see list1
Suppliers: see list1

Pharmacology for Ingredient: nelarabine

Clinical Trials for: nelarabine

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
Status: Recruiting Condition: Relapsed T-Cell Acute Lymphoblastic Leukemia; Relapsed T-Cell Lymphoblastic Lymphoma

Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies
Status: Recruiting Condition: Leukemia

Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Status: Completed Condition: Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic; Lymphoblastic Lymphoma; Acute Lymphoblastic Leukemia

Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma
Status: Recruiting Condition: Leukemia; Lymphoblastic Lymphoma; Leukemia, Lymphoblastic, Acute

506U78 in Treating Patients With Lymphoma
Status: Completed Condition: Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Small Intestine Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome

506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Status: Terminated Condition: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome

Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
Status: Active, not recruiting Condition: Cancer

506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Status: Completed Condition: T-ALL, T-NHL (Lymphoblastic)

Observational Study of Nelarabine in Children and Young Adults
Status: Completed Condition: Leukaemia, Lymphoblastic, Acute

506U78 in Treating Patients With Refractory Hematologic Cancer
Status: Completed Condition: Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Childhood Acute Lymphoblastic Leukemia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Smithkline Beecham
INJECTABLE;IV (INFUSION)021877Oct 28, 2005RXYes5,424,295<disabled>YY<disabled>
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Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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