FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc. ’s generics of Prograf (tacrolimus) oral capsules
Based on new data, the U.S. Food and Drug Administration is changing the therapeutic equivalence rating for tacrolimus oral capsule products manufactured by Accord Healthcare Inc. under abbreviated new drug application 091195. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Tacrolimus After Lung Transplant Cuts Chronic Lung Allograft Dysfunction
(MedPage Today) -- MILAN -- Once-a-day tacrolimus significantly reduced chronic lung allograft dysfunction (CLAD) in lung transplant patients compared with the standard immunosuppressant, according to the ScanCLAD trial.
Among patients who underwent... (Source: MedPage Today Surgery)
Source: MedPage Today Surgery - September 11, 2023 Category: Surgery Source Type: news
Meta-Analysis Points to Most Effective Topical Treatments for Atopic Dermatitis
(MedPage Today) -- Pimecrolimus, tacrolimus, and moderate-potency topical corticosteroids (TCS) are the most effective in the treatment of atopic dermatitis (AD), according to a systematic review and meta-analysis.
High-certainty evidence showed... (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - September 8, 2023 Category: Allergy & Immunology Source Type: news
Dr Reddy's Lab recalls over 4,000 bottles of generic drug in US
New Jersey-based Dr Reddy's Laboratories Inc, a unit of the company, is recalling the affected lot due to "Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules," USFDA said in its latest Enforcement Report. The affected lot was produced at the company's Bachupally-based manufacturing plant and marketed in the US by its American arm. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 7, 2023 Category: Pharmaceuticals Source Type: news
Tacrolimus Variability Explored in Peds Kidney Transplant Recipients
THURSDAY, July 28, 2022 -- For pediatric kidney transplant recipients, tacrolimus intrapatient variability is associated with C1q-binding de novo donor-specific antibody formation, according to a study published online July 26 in the Clinical... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 28, 2022 Category: Pharmaceuticals Source Type: news
Can You Put Tacrolimus on Genitals?
Title: Can You Put Tacrolimus on Genitals?Category: Diseases and ConditionsCreated: 6/7/2022 12:00:00 AMLast Editorial Review: 6/7/2022 12:00:00 AM (Source: MedicineNet Skin General)
Source: MedicineNet Skin General - June 7, 2022 Category: Dermatology Source Type: news
Tacrolimus Measures Up in Lupus Nephritis Trial
(MedPage Today) -- In a phase III trial, oral tacrolimus (Prograf) proved non-inferior to intravenous cyclophosphamide for treating lupus nephritis, researchers said.
Among 158 patients randomized to tacrolimus, 83.0% achieved complete or partial... (Source: MedPage Today Rheumatology)
Source: MedPage Today Rheumatology - March 30, 2022 Category: Rheumatology Source Type: news
Tacrolimus Tied to Post Liver Transplant Cancer Risk Tacrolimus Tied to Post Liver Transplant Cancer Risk
Higher cumulative exposure to tacrolimus in the first year after liver transplant was linked to a higher risk for de novo malignancies and recurrent liver cancer in a case-control study from Spain.Reuters Health Information (Source: Medscape Transplantation Headlines)
Source: Medscape Transplantation Headlines - March 23, 2022 Category: Transplant Surgery Tags: Transplantation News Source Type: news
The future is bright for RWE in pharma approvals
Real-world evidence (RWE) could help pharma achieve many things – including understanding disease burden better and smarter monitoring of newly marketed therapies to make them safer and more effective. But the most promising near-term use case for RWE, according to a Deloitte survey of pharma executives, is in support of regulatory submissions and label expans ion. For industry stakeholders such as Marc Berger, M.D., this advance is a long time coming. The founder of the real-world data (RWD) and analytics group at Pfizer, Berger has been a contributing author on dozens of policy papers on the use of RWE – including ...
Source: EyeForPharma - January 6, 2022 Category: Pharmaceuticals Authors: Brian Eastwood Source Type: news
FDA approves new use of transplant drug based on real-world evidence
Approval of Prograf (tacrolimus) Using Real-World Evidence (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness
FDA recently approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection in adult and pediatric patients receiving lung transplantation. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
U.S. Food and Drug Administration Expands Indication for Prograf for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tacrolimus for Lung Transplants FDA Approves Tacrolimus for Lung Transplants
The drug is the only immunosuppressant approved for the prevention of organ rejection in both adult and pediatric patients undergoing lung transplant. It has been used in lung transplant for 15 years.FDA Approvals (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - July 19, 2021 Category: Surgery Tags: Transplantation News Alert Source Type: news
FDA Approves New Use of Transplant Drug Based on Real-World Evidence
Approval of Prograf (Tacrolimus) Using Real-World Evidence (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sitagliptin Promising Addition for Preventing Acute GVHD
THURSDAY, Jan. 7, 2020 -- For patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation, sitagliptin combined with tacrolimus and sirolimus results in a low incidence of grade II to IV acute graft-versus-host disease... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 7, 2021 Category: Pharmaceuticals Source Type: news
