Navigation Links
Update on Astellas' Request for Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
Date:8/12/2009

DEERFIELD, Ill., Aug. 12 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas") announced today an update regarding the status of the request for emergency relief and preliminary injunction from the U.S. Food and Drug Administration's (FDA) decision regarding its Citizen Petition. The company's requests have been denied by the U.S. District Court in Washington, D.C. The company is disappointed in the court's decision and is currently evaluating its next course of action.

The Citizen Petition requested that the FDA ensure the safe and effective use of immunosuppressants (also called anti-rejection medications) used to prevent rejection in organ transplant patients. The petition sought additional measures from the FDA to protect transplant recipients from substitute critical dose immunosuppressant drugs that have not demonstrated bioequivalence in rigorous clinical trials in transplant patients. On August 10, 2009, the FDA substantially denied the Citizen Petition and approved an Abbreviated New Drug Application (ANDA) for generic tacrolimus. On August 11, 2009, Astellas requested the U.S. District Court in D.C. to issue a temporary restraining order enjoining the FDA's approval of the ANDA for tacrolimus.

"As a leader in the field of transplantation, Astellas remains firmly committed in our efforts to providing appropriate care as well as safe and effective treatments for this unique and vulnerable patient population," said William E. Fitzsimmons, Pharm.D., M.S., Senior Vice President, Development. "We are disappointed in the decision of the judge to not grant emergency relief, and are evaluating all options available to us."

About Organ Transplantation

There are nearly 100,000 patients on the waiting list for an organ transplant and 4,000 patients are added to the list each month. Each day, on average, seventeen patients on the list die waitin
'/>"/>

SOURCE Astellas Pharma US, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine news :

1. Nutrition 21 Announces Preliminary Fourth Quarter Financial Update Also Announces Negotiations on Notes due August 25, 2009
2. China Pharma Holdings, Inc. Reports Second Quarter 2009 Financial Results and Corporate Updates
3. Video: Provectus Pharmaceuticals Updates Shareholders On 2009 Year-To-Date Accomplishments
4. GeoVax Labs, Inc. Announces Six Month 2009 Financial Results and Provides Operational Update
5. Warner Chilcott Reports Operating Results for the Quarter Ended June 30, 2009 and Updates 2009 Full Year Guidance
6. Air Methods Reports 2Q2009 Results and 3Q2009 Update
7. NutraCea Announces Forbearance Agreement With Bank and Provides Update on Business Strategy and Transactions
8. Decision Resources Updated Rheumatoid Arthritis Report Now Includes Forecast for Rigel Pharmaceuticals Fostamatinib Disodium
9. ULURU Inc. Announces Conference Call to Discuss Financial Results for the Second Quarter Ended June 30, 2009 and to Provide a Business Update
10. NCCN Updates Infection Guidelines to Include Information About H1N1 Virus (Swine Flu)
11. BioCryst Reports Second Quarter 2009 Financial Results And Provides Corporate Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2013)... FRIDAY, May 24 (HealthDay News) -- Low-income, minority ... sexual activity and are more open to vaccinating ... (HPV), a small new study contends. Conversely, ... off vaccination for their daughters, according to researchers ... "Approximately 33,000 Americans will get an HPV-related cancer ...
(Date:5/24/2013)... CA (PRWEB) May 24, 2013 American ... care education community, proudly participated in festivities surrounding the ... 19-21. The event provided the perfect backdrop to introduce ... at 236 E. 3rd Street, housed in an architectural ... Building. , ACC was an active exhibitor throughout the ...
(Date:5/24/2013)... 24, 2013 The SunglassFIX Photo ... sunglasses all while learning how to make their ... Contestants only need to upload pictures of ... "like" The Sunglass Fix on Facebook in order ... the largest lens replacement online store . ...
(Date:5/24/2013)... A new discovery at Oregon Health & Science ... effectively reacts when infected with the highly evasive HIV ... has been utilizing this unique approach to develop its ... promising results in animal studies. This latest research finding ... of the journal Science . , "A ...
(Date:5/24/2013)... 2013 Residents of San Diego have ... classes. Fitness expert, and Certified Russian Kettlebell Instructor, Cody ... Bootcamps in San Diego, California. The classes take place ... times offered. Initial sign-ups are available online and ... teaching Kettlebell for years. The bootcamps being offered ...
Breaking Medicine News(10 mins):Health News:Low-Income, Minority Parents More Open to HPV Vaccine for Girls, Study Says 2Health News:American Career College Revs Up Community Support During Toyota Grand Prix of Long Beach 2Health News:Break the Sunglass Mold – Reuse 'Em, Don’t Toss 'Em then Enter the SunglassFIX Photo Contest to Win 2Health News:OHSU research highlights promising strategy to help vaccines outsmart HIV 2
... ... with a plan that is customized to them? Want to keep the weight off permanently and ... , ... Loss announces that the new online company continues to expand its website and its customer base, ...
... ... invasive approaches toward imaging-guided percutaneous—or through the skin—techniques, according to a new study appearing ... , ... IL (Vocus) June 29, 2010 -- Advanced imaging technologies have helped shift biopsy techniques ...
... Gardner HealthDay Reporter , MONDAY, June 28 ... clinical trials, the diabetes drug Avandia does raise the odds ... drug,s risks might outweigh its benefits in people with type ... increased risk for death from cardiovascular disease, said the authors ...
... , MONDAY, June 28 (HealthDay News) -- A new study ... statins are a third less likely to suffer from recurrences ... prescribe a statin -- drugs such as Crestor, Lipitor ... aren,t firm enough for doctors to make a blanket recommendation ...
... anterior cruciate ligaments (ACL) or meniscal cartilage injuries in the ... to a new study published in the online edition and ... A decade after the initial injuries were diagnosed using ... whether or not the injuries had been surgically repaired. ...
... for watching too much TV. It turns out that their ... TV, and it is not good for them either, according ... and Rady School of Management at the University of California, ... online in advance of publication in the August issue of ...
Cached Medicine News:Health News:Brilliance Weight Loss Takes Dieters Beyond Trendy Low Fat Diets 2Health News:Use of Less Invasive, Imaging-Guided Biopsies on the Rise 2Health News:Use of Less Invasive, Imaging-Guided Biopsies on the Rise 3Health News:Diabetes Drug Avandia Ups Heart Risk, Reviews Conclude 2Health News:Diabetes Drug Avandia Ups Heart Risk, Reviews Conclude 3Health News:Diabetes Drug Avandia Ups Heart Risk, Reviews Conclude 4Health News:Statins May Lower Rates of Prostate Cancer Recurrence 2Health News:Surgical repair of knee injuries does not decrease risk of osteoarthritis 2Health News:Older adults watch more TV than younger people, enjoy it less 2
(Date:5/23/2013)... 23, 2013  TeamHealth Medical Call Center (THMCC), ... nurse advice lines, announces its newly formed Clinical ... and administrative leaders, provides clinical expertise to advance ... services for hospital clients, physician clients and patients. ... evolves, it,s imperative to continuously advance our services ...
(Date:5/23/2013)... , May 23, 2013  The need to ... treatment continuum was highlighted prominently at the 108 ... Association (AUA), in San Diego.  According to SonaCare ... focused ultrasound (HIFU) technology, the need for image-guided ... for urologists to consider minimally invasive ablative treatments, ...
(Date:5/23/2013)... 2013  Texas, premier physician associations today announced the ... tools they need to provide demonstrably better and more ... marketplace. "I am confident the Physician Services ... Stephen L. Brotherton , MD, president ... doctors are determined to make health care ...
Breaking Medicine Technology:TeamHealth Medical Call Center Forms Clinical Advisory Committee 2Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 2Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 3Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 4Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 5Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 6TMA Launches Physician Services Organization for Patient Care 2TMA Launches Physician Services Organization for Patient Care 3TMA Launches Physician Services Organization for Patient Care 4
... Fla., Nov. 13 /PRNewswire/ Millar Instruments, Inc., developer ... pressure-volume (P-V) systems, and Transonic Systems, Inc., global ... flow measurement devices, today announce a new distribution ... two giants in the field of physiological measurements, ...
... , SUNNYVALE, Calif., Nov. 13 Walt Maclay, ... ), has been selected to speak on "Data ... on December 9, 2009. BIOMEDevice ( http://www.devicelink.com/expo/biomed09/index.html ... together industry leaders in medical devices. The show ...
Cached Medicine Technology:Millar Instruments and Transonic Systems, Suppliers of Gold Standard Pressure and Flow Products, Enter Into Mutual Distribution Agreement 2Voler Systems President Speaks at BIOMEDevice San Jose 2Voler Systems President Speaks at BIOMEDevice San Jose 3
The Storz Premiere comes as anterior, posterior and anterior/posterior combo. The combo provides the following modes irrigation, irrigation/aspiration, vitrectomy, and illumination....
... Phacoemulsification System is a ... system. Lightweight and portable, ... and features in a ... provides all modes necessary ...
Compact ultrasonic phacoemulsification system....
Phaco-emulsification systems CV series...
Medicine Products: