« Return to News | Clinical Intelligence

Astellas receives FDA approval of ASTAGRAF XL

Wednesday, July 24, 2013 10:15 AM

Astellas Pharmasaid the FDA has approved ASTAGRAF XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

ASTAGRAF XL is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients. ASTAGRAF XL offers a potentially promising treatment option for appropriate kidney transplant recipients as a core component of an immunosuppressive regimen for the prophylaxis of organ rejection.

The two primary, randomized, comparative phase III clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. 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 73 countries.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.