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Profile for Tradename: PROGRAF

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Prograf is a drug marketed by Astellas and is included in two NDAs. It is available from four suppliers.

The generic ingredient in PROGRAF is tacrolimus. There are seventeen drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the tacrolimus profile page.

Summary for Tradename: PROGRAF

Patents:0
Applicants:1
NDAs:2
Suppliers: see list4

Pharmacology for Tradename: PROGRAF

Clinical Trials for: PROGRAF

A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
Status: Recruiting Condition: Liver Transplantation

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
Status: Recruiting Condition: Renal Transplantation

Prograf-Advagraf Cross Over Conversion Study
Status: Completed Condition: Kidney-Pancreas Transplantation

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
Status: Recruiting Condition: Liver Transplantation

Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
Status: Completed Condition: Liver Failure

A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
Status: Completed Condition: Kidney Transplantation

Multictr, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
Status: Completed Condition: Renal Failure

Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
Status: Completed Condition: Kidney Transplantation; Renal Transplantation

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
Status: Completed Condition: Liver Transplantation

Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708-002Apr 8, 1994RXYes<disabled><disabled>
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709-001Apr 8, 1994RXYes<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708-003Aug 24, 1998RXNo<disabled><disabled>
Astellas
PROGRAF
tacrolimus
CAPSULE;ORAL050708-001Apr 8, 1994RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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