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 approved for use in 69 countries resulting in more than 140,000 patient years of experience.

About Astellas

Astellas Pharma US, Inc., located in Northbrook, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma US, Inc., please visit our website at www.Astellas.us or www.AstellasTransplant.com.

Astellas is a recognized leader in transplantation and has been committed to the field of immunology for more than 20 years. Dedicated to supporting the advancement of care for patients, Astellas continues to build upon its legacy and leadership in transplantation by investing in ongoing clinical research and new product development.


'/>"/>
SOURCE Astellas Pharma US, Inc.
Copyright©2012 PR Newswire.
All rights reserved

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:1/16/2017)... PUNE, India , January 16, 2017 ... "Vital Signs Monitoring Devices Market by Type and End User: ... global vital signs monitoring devices market size was worth $3,694 ... by 2022, growing at a CAGR of 5.8% from 2016 ... leading regional market in global vital signs monitoring devices industry. ...
(Date:1/16/2017)... , January 16, 2017 ... Derivatives Market by Product Type (Methyl, Ethyl, Hydroxyethyl, ... Foods & Beverages, Surface Coatings & Paints), ... by MarketsandMarkets, the market was valued at ... projected to reach USD 6.41 Billion by ...
(Date:1/16/2017)... N.J. , Jan. 16, 2017   Linde Gas ... all of the assets and business of The Service Center ... equipment repair services to healthcare providers in the Midwest and ... Broadview, Illinois , The Service Center also ... Greenville, South Carolina . Its primary services ...
Breaking Medicine Technology:
(Date:1/16/2017)... ... January 16, 2017 , ... Atlanta-based incentive ... an innovator in the wheelchair accessibility industry, BraunAbility . Incentive Solutions will ... sell wheelchair accessible vehicles. With this new incentive plan, BraunAbility plans to continue ...
(Date:1/16/2017)... ... January 16, 2017 , ... In ... education and high-level training standards to an international multidisciplinary group of healthcare treatment ... As a way to further its mission at the grassroots level, iaedp launched ...
(Date:1/16/2017)... ... 2017 , ... NexTec Group has been selected as a member of the ... accomplishments in the field of midmarket financial software. , Members of the VAR Stars ... is not based on revenue and those firms chosen represent a wide range of ...
(Date:1/15/2017)... ... 2017 , ... Accreditation Commission for Health Care (ACHC) is ... services. Albertsons Companies is the largest national food and drug chain with ... Accreditation by ACHC reflects Albertsons Companies’ dedication and commitment to meeting national standards ...
(Date:1/15/2017)... Radnor, Pa. (PRWEB) , ... January 15, 2017 , ... ... its newest location in Radnor, Pennsylvania. As construction wraps up on the 14,000+ square ... be The Gravity Vaults sixth location, including three in New Jersey and two in ...
Breaking Medicine News(10 mins):