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Details for Generic Name: zileuton

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Zileuton is the generic ingredient in two branded drugs marketed by Chiesi Usa Inc and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for zileuton. One supplier is listed for this compound.

Summary for Generic Name: zileuton

Tradenames:2
Patents:0
Applicants:1
NDAs:2
Drug Master File Entries: see list6
Suppliers: see list1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: zileuton

Clinical Trials for: zileuton

Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia
Status: Recruiting Condition: Chronic Myelogenous Leukemia

Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
Status: Not yet recruiting Condition: Lung Carcinoma; Tobacco Use Disorder

Trial of Zileuton CR in Children and Adults With Sickle Cell Disease
Status: Completed Condition: Sickle Cell Disease

Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML.
Status: Terminated Condition: Chronic Myelogenous Leukemia

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers
Status: Completed Condition: Tobacco Use Disorder

Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS
Status: Terminated Condition: Asthma

Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients
Status: Completed Condition: Asthma

Zileuton and Exhaled Nitric Oxide in Asthmatics
Status: Completed Condition: Asthma

Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Status: Completed Condition: Idiopathic Pulmonary Fibrosis

Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
Status: Terminated Condition: Pulmonary Disease, Chronic Obstructive

Courtesy of ClinicalTrials.org
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
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-003Dec 9, 1996RXYes<disabled><disabled>
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-001Dec 9, 1996DISCNNo<disabled><disabled>
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 2007RXYes<disabled><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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