Navigation Links
Astellas Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules
Date:12/4/2012

NORTHBROOK, Ill., Dec. 4, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for tacrolimus extended release capsules, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Based upon the September receipt of the NDA submission, the FDA Prescription Drug User Fee Act (PDUFA) review date will be July 21, 2013.

"The NDA acceptance for tacrolimus extended release capsules marks an important step toward addressing the unmet treatment need for transplant recipients who have difficulty controlling their immunosuppression drug levels with existing products," said Roy First, MD, Astellas Global Therapeutic Area Head for Transplantation. "Astellas has been committed to the field of immunology for more than 20 years and plans to continue that commitment by working to bring promising new treatments for patients to market."

Developed by Astellas, tacrolimus extended release capsules are a once daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus. The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 (393 tacrolimus extended release) liver transplant recipients conducted in the U.S., Canada, Europe, Australia, Brazil, New Zealand, among other sites. Astellas also has more than five years of follow-up patient data from the treatment of transplant recipients with tacrolimus extended release capsules.

Astellas was granted marketing approval for tacrolimus extended release capsules under the trade name Advagraf® in Europe in 2007 and under the trade name Graceptor® in Japan in 2008. In total, tacrolimus extended release capsules have been
'/>"/>

SOURCE Astellas Pharma US, Inc.
Copyright©2012 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related medicine technology :

1. Personal Connections Drive Employee Participation For Changing Tomorrow Day at Astellas
2. Astellas to Close Urogenix, North Carolina-based Urology Research Facility
3. Astellas and Fujita Health University Discover Neuronal Maturation Deficits in Patients Suffering from Schizophrenia and Bipolar Disorder
4. First sales of DIFICLIR™ by Astellas Pharma Europe triggers 10 Million Euro Milestone Payment to Optimer Pharmaceuticals
5. Perrigo Company Announces The Appointment Of Industry Veteran To Executive Vice President And General Manager, Rx
6. Ultra Clean Announces Participation in the Midtown CAP Summit Investor Conference
7. MetaStat Announces Presentations at the 2012 San Antonio Breast Cancer Symposium
8. Young Innovations Announces Definitive Agreement to be Acquired by Linden Capital Partners
9. ObeTherapy Announces the Publication of Results Obtained with one of its Lead Compounds on a New Target for the Treatment of Obesity and Type II Diabetes
10. GDS International Announces "Industry Leader of the Year" Award at its Fourth Annual European Pharmaceutical Drug Discovery Summit
11. Elbit Imaging Ltd. Announces InSightecs ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... 2013  AbbVie (NYSE: ABBV ) ... clinical study called SONAR (Study Of Diabetic Nephropathy ... investigational compound atrasentan - when added to standard of ... with stage 2 to 4 chronic kidney disease ... large, multinational, double-blind, placebo-controlled clinical study that is ...
(Date:5/19/2013)... ORLANDO, Fla. , May 19, 2013 /PRNewswire/ ... power and low temperature radiofrequency (RF) energy is ... and eliminates or reduces the need for medication ... long-term assessment presented today at the Digestive Disease ... Orlando, Florida . ...
(Date:5/17/2013)... SHANGHAI , May 17, 2013 Medical ... drug nor a biological product. In light of their ... trail evaluations are much more complicated than drug trails ... only evaluates MD safety instead of evaluating both safety ... the US FDA (which is the same as the ...
Breaking Medicine Technology:AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy 2AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy 3AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy 4AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy 5AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy 6Stretta Procedure for GERD: Successful 10 Year Follow-Up Data Presented at Digestive Disease Week--Sustained Improvement, Long-Term Efficacy 2Stretta Procedure for GERD: Successful 10 Year Follow-Up Data Presented at Digestive Disease Week--Sustained Improvement, Long-Term Efficacy 3Statistical Challenges in Medical Device Trail Evaluation 2
... Inc., a market leader in PyroCarbon orthopedic implants, announces ... than 40,000 PyroCarbon extremity joint replacements worldwide. ... of Ascension Orthopedics, pioneered efforts using PyroCarbon in the ... His collaborative efforts with the Mayo Clinic lead to ...
... Reportlinker.com announces that a new market research report ... Probiotics and Prebiotics in Clinical Nutrition ... Overall sales of clinical nutrition products are ... EU as well as rising incidence of illnesses and ...
Cached Medicine Technology:Ascension Orthopedics Reaches Milestone With Distribution of 40,000 PyroCarbon Implants 2Reportlinker Adds Probiotics and Prebiotics in Clinical Nutrition 2Reportlinker Adds Probiotics and Prebiotics in Clinical Nutrition 3Reportlinker Adds Probiotics and Prebiotics in Clinical Nutrition 4
(Date:5/20/2013)... , , MONDAY, May 20 (HealthDay News) -- The older ... the late 1990s is more effective than the current ... Teenagers who received four shots with the older vaccine ... years old were significantly less likely to become infected ... compared to children who received all of their immunizations ...
(Date:5/20/2013)... ARBOR, Mich. As high schoolers prepare for final ... "study drug" -- a prescription stimulant or amphetamine -- ... of Michigan poll shows only one in 100 parents ... has used a study drug., Study drugs refer to ... deficit hyperactivity disorder (ADHD); commonly prescribed medicines in this ...
(Date:5/20/2013)... May 20, 2013 Medicare Part D ... satisfied, citing lower costs, convenient access to pharmacies and ... Research Associates released today by the Pharmaceutical Care Management ... (9.5 million) are currently enrolled in plans with preferred ... and overall value of plans with preferred pharmacy networks,” ...
(Date:5/20/2013)... It’s May which means it’s Bike Month! If you ... those dusty bikes and helmets. , Windsong Production's and BLARE ... the office with Windsong Productions challenging BLARE ... miles for the 4th Annual Million Mile Challenge. They may ... *insert battle prep montage* , This is all part of ...
(Date:5/20/2013)... 20, 2013 6Webs.com is the leading ... reviews . 6Webs.com recently completed their assessments of the ... are completed annually and the top home security system ... their monitoring technology, equipment and warranties to mention a ... the 6Webs.com team completed the home security reviews, numerous ...
Breaking Medicine News(10 mins):Health News:Study: Older Whooping Cough Vaccine More Effective 2Health News:Study: Older Whooping Cough Vaccine More Effective 3Health News:1 in 10 teens using 'study drugs,' but parents aren't paying attention 2Health News:Survey: 85% of Part D Seniors in Preferred Pharmacy Plans are Satisfied With Costs, Pharmacy Choices 2Health News:Best Home Alarm System Companies in 2013 Published by Leading Security Reviews Site - 6Webs.com 2
... oral drug bosentan (Tracleer) has led to significant improvements ... PAH) // . ,PAH is usually linked with ... cause the overproduction of endothelin, which increases the chance ... obstruction leads to PAH, a condition that in most ...
... shows a diet rich in omega-3 and omega-6 fatty acids may ... Researchers say they studied mice to determine the effects of a ... animals were divided into four groups. The first received a diet ... a diet rich in omega-6 fatty acids along with the drug ...
... to latest research patients who were treated for depression ... vitamin B12 in their blood.// An increasing amount of ... and depression, but the specifics have not been understood. ... of vitamin B12 and the treatment of depression. ...
... researchers find people who get only four hours a night have ... to weight gain. ,An investigation was conducted among 12 ... the study started, after they had slept about four hours a ... hours a night for two nights. Levels of leptin, which sends ...
... the market are losing their effectiveness, since most of ... that the ocean is a new place to look ... microorganisms fill every milliliter of seawater. Each one could ... deadliest diseases. Many marine organisms are already in development ...
... a month’s time from now five-year-old Hussain Abbas and Mohamed ... as normal children.// Part of a contingent of 20 Iraqi ... complicated cardiac problems by the Much Acclaimed heart surgeon Dr ... assessment this evening by a paediatric cardiac physician and are ...
Cached Medicine News:
...
Malis Curette, bayonet, titanium handle, stainless steel shaft, working distance 102 mm, length 203 mm....
Sundt Slim-Line Temporary Vessel Clips used for temporary vascular occlusion during intracranial surgical procedures. Non-magnetic, MP35N, MRI compatible, gold color. Bayonet....
Malis Needle Holders, bayonet, titanium. Working distance 2 1/2" (63 mm). Straight tip with width 0.6 mm....
Medicine Products: