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Profile for Tradename: DIGOXIN

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Digoxin is a drug marketed by Roxane, Abraxis Pharm, Hikma Maple , Hospira, Sandoz, Wyeth Ayerst, Hikma Intl Pharms, Impax Labs, Mylan Pharms Inc, Stevens J, and Sun Pharm Inds Inc. and is included in thirteen NDAs. It is available from three suppliers.

The generic ingredient in DIGOXIN is digoxin. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for Tradename: DIGOXIN

Patents:0
Applicants:11
NDAs:13
Suppliers: see list3

Pharmacology for Tradename: DIGOXIN

Ingredient-typeCardiac Glycosides
Drug ClassCardiac Glycoside

Clinical Trials for: DIGOXIN

Digoxin Dosing in Heart Failure: A Simplified Nomogram Versus Standard Care
Status: Completed Condition: Heart Failure

Drug Interaction Study of Isavuconazole and Digoxin
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Digoxin; Healthy Volunteers

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects
Status: Completed Condition: Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction (DDI)

A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults
Status: Completed Condition: Healthy Volunteer

Drug Interaction Study of Digoxin and BI 10773
Status: Completed Condition: Healthy

to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
Status: Completed Condition: Healthy

Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
Status: Completed Condition: Healthy; HIV Infections

A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin
Status: Completed Condition: Healthy

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.
Status: Completed Condition: Healthy

Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Status: Completed Condition: Type 2 Diabetes Mellitus

An Open-label, Single-centre Study Evaluating the Pharmacokinetics of Digoxin Alone and When Administered at Various Doses of Ezogabine/Retigabine in Healthy Adults. The Pharmacokinetics of Ezogabine/Retigabine and the N-acetyl Metabolite of Ezogabine/Retigabine (NAMR) Will Also be Assessed
Status: Completed Condition: Epilepsy

A Drug Interaction Study of Albiglutide and Digoxin
Status: Completed Condition: Diabetes Mellitus, Type 2; Healthy

Role of SNP and DIGOXIN Response in Atrial Fibrillation Patients
Status: Recruiting Condition: Atrial Fibrillation

Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib
Status: Completed Condition: Healthy Volunteers

A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy Subjects
Status: Completed Condition: Healthy; Pharmacokinetic of Digoxin

Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects
Status: Completed Condition: Alzheimer Disease; Huntington Disease

A Study to Evaluate the Effect of a Single Dose of Digoxin on the Actions in the Bodies of Healthy Subjects After Having Taken Several Doses of YM178
Status: Completed Condition: Healthy

Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer
Status: Completed Condition: Metastatic ErbB2; Neoplasms, Breast; Breast Cancer

Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure
Status: Completed Condition: Cardiac Failure

A Trial of Digoxin Before Second-Trimester Abortion
Status: Completed Condition: Induced Abortion

Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects
Status: Completed Condition: Healthy Volunteers; Rheumatoid Arthritis

Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin
Status: Completed Condition: DRUG REACTIONS

Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
Status: Active, not recruiting Condition: Healthy

A Study of Evacetrapib and Digoxin in Healthy Participants
Status: Completed Condition: Healthy Volunteers

Capecitabine With Digoxin for Met Breast Cancer
Status: Recruiting Condition: Metastatic Breast Cancer

Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion
Status: Completed Condition: Abortion, Induced

Digoxin Withdrawal in Stable Heart Failure
Status: Recruiting Condition: Heart Failure

Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction
Status: Recruiting Condition: Heart Failure

A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Status: Completed Condition: Healthy Volunteers

Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
Status: Completed Condition: Cardiac Failure With Sinus Rhythm or Atrial Fibrillation.

A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants
Status: Completed Condition: Diabetes Mellitus, Type 2

Pharmacokinetics, Safety and Tolerability of Digoxin With or Without Co-administration of BI 1356 in Healthy Volunteers
Status: Completed Condition: Healthy

Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
Status: Completed Condition: N/A - Healthy Subjects

Phase II Multicentric Study of Digoxin Per os in Classic or Endemic Kaposi' s Sarcoma
Status: Not yet recruiting Condition: Kaposi' s Sarcoma; Classic Kaposi' s Sarcoma; Endemic Kaposi' s Sarcoma; Lymph Angio Proliferations

TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and Rosuvastatin
Status: Completed Condition: Hepatitis C Virus

Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin
Status: Completed Condition: Healthy Volunteers; Pharmacokinetics

Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer
Status: Terminated Condition: Carcinoma, Non-Small Cell Lung

DIG-HIF1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
Status: Recruiting Condition: Breast Cancer

Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study of LY2216684 and Digoxin in Healthy Subjects
Status: Completed Condition: Major Depressive Disorder

Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy
Status: Not yet recruiting Condition: Arrhythmia; ECG Changes; Hypotension

Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.
Status: Recruiting Condition: Neoplasms

Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects
Status: Active, not recruiting Condition: Diabetes; Healthy

A Drug-Drug Interaction Study of Digoxin and PA21
Status: Completed Condition: Drug Interaction Potentiation

Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects
Status: Active, not recruiting Condition: Diabetes; Healthy

Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects
Status: Completed Condition: Solid Tumors

Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin
Status: Completed Condition: Healthy

DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Status: Recruiting Condition: Healthy

A Phase 1B Clinical Trial of Trametinib Plus Digoxin in Patients With Unresectable or Metastatic BRAF Wild-type Melanoma
Status: Recruiting Condition: Melanoma

A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers
Status: Completed Condition: Healthy Volunteer

A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Status: Completed Condition: Malignant Melanoma, Neoplasms

Digoxin for Recurrent Prostate Cancer
Status: Completed Condition: Prostate Cancer

A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
Status: Completed Condition: Healthy Subjects

An Interaction Study With Digoxin and AZD1305
Status: Completed Condition: Atrial Fibrillation

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers
Status: Completed Condition: Drug-drug Interaction Study

Relative Bioavailability of Dabigatran and Digoxin in Healthy Male and Female Volunteers
Status: Completed Condition: Healthy

A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
Status: Completed Condition: Essential Hypertension

Phase I Interaction Study of Istaroxime and Digoxin in Subjects With Stable Heart Failure
Status: Withdrawn Condition: Heart Failure

A Preliminary Drug Drug Interaction Study With TA-8995
Status: Completed Condition: Pharmacokinetic Interactions

Antibodies to Digoxin for Bipolar Disorder
Status: Completed Condition: Bipolar Disorder

Efficacy Study of Digibind for Treatment of Severe Preeclampsia
Status: Completed Condition: Pre-eclampsia

Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Status: Completed Condition: Heart Diseases

Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
Status: Recruiting Condition: Depression

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)
Status: Active, not recruiting Condition: Healthy

Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH
Status: Completed Condition: Diabetes; Healthy

An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
Status: Completed Condition: Epilepsy

Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia
Status: Completed Condition: Supraventricular Tachycardia

Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
Status: Completed Condition: Alzheimer Disease

Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
Status: Completed Condition: Healthy

Drug-Drug Interaction Study in Health Adult Volunteers
Status: Completed Condition: Healthy

Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease
Status: Active, not recruiting Condition: Hypertension; Hemodialysis

Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers
Status: Completed Condition: Healthy

Digoxin Drug-Drug Interaction With Lurasidone HCl
Status: Completed Condition: Schizophrenia

Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department
Status: Recruiting Condition: Atrial Fibrillation

Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services
Status: Recruiting Condition: Legally Induced Abortion Without Mention of Complication

Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
Status: Completed Condition: Hepatitis C

Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)
Status: Completed Condition: Atrial Fibrillation

Role of CYP2B6, CYP3A4, and MDR1 in the Metabolic Clearance of Methadone
Status: Recruiting Condition: Substance-Related Disorders

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Status: Recruiting Condition: Postoperative Atrial Fibrillation

Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients
Status: Terminated Condition: Heart Failure; Heart Murmurs

Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
Status: Completed Condition: Abortion, Induced

Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Status: Completed Condition: Atrial Fibrillation; Arrhythmia

Effect of Garlic Supplements on Opioids in Healthy Volunteers
Status: Completed Condition: Healthy, no Evidence of Disease

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
Status: Completed Condition: Arrhythmia; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases

Pulmonary Arterial Denervation in Patients With Pulmonary Arterial Hypertension Associated With the Left Heart Failure
Status: Recruiting Condition: Pulmonary Hypertension

Effects of Amlodipine in the Management of Chronic Heart Failure
Status: Suspended Condition: Chronic Heart Failure

Rhythm Control of AF in Patients With Acute Stroke
Status: Not yet recruiting Condition: Atrial Fibrillation

Remission From Stage D Heart Failure
Status: Recruiting Condition: NYHA Class IIIB/IV Patients Eligible for HeartMate II Implant Either as BTT or DT

Catheter Ablation Versus Medical Treatment of AF in Heart Failure
Status: Recruiting Condition: Atrial Fibrillation; Heart Failure

ALERT-HF: Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure
Status: Completed Condition: Chronic Heart Failure

The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
Status: Completed Condition: Cardiomyopathy, Hypertrophic

Metabolic Syndrome and Atrial Fibrillation
Status: Recruiting Condition: Atrial Fibrillation; Metabolic Syndrome; Oxidative Stress; Atherosclerosis; Disorders, Blood Coagulation

Enalapril After Anthracycline Cardiotoxicity
Status: Completed Condition: Cardiovascular Diseases; Heart Diseases; Heart Failure; Myocardial Diseases

Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation
Status: Terminated Condition: Atrial Fibrillation

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Status: Recruiting Condition: ST Elevation Myocardial Infarction

Mifepristone and Mid-Trimester Termination of Pregnancy
Status: Completed Condition: Abortion, Induced; Abortion, Second Trimester

Selective AV Nodal Vagal Stimulation For Reduction of the Ventricular Rate During Atrial Fibrillation
Status: Withdrawn Condition: Atrial Fibrillation

Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation
Status: Recruiting Condition: Atrial Fibrillation

Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter
Status: Completed Condition: Heart Rate and Rhythm Disorders

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs
DIGOXIN
digoxin
TABLET;ORAL078556Jul 20, 2009RXNo<disabled><disabled>
Stevens J
DIGOXIN
digoxin
TABLET;ORAL076268Jul 26, 2002RXNo<disabled><disabled>
Hospira
DIGOXIN
digoxin
INJECTABLE;INJECTION040206Aug 28, 1998DISCNNo<disabled><disabled>
Roxane
DIGOXIN
digoxin
ELIXIR;ORAL021648Aug 26, 2004RXYes<disabled><disabled>
Hospira
DIGOXIN PEDIATRIC
digoxin
INJECTABLE;INJECTION040092Apr 25, 1996DISCNNo<disabled><disabled>
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