Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Japan Approves Astellas Transplant Drug Delayed In U.S.

This article was originally published in PharmAsia News

Executive Summary

Astellas Pharma said it has won approval to market its Graceptor (tacrolimus) transplant drug in Japan. The new version is a once-daily form of Astellas' twice-daily Prograf, a $2 billion-a-year seller for the company, but one that lost its U.S. patent protection earlier this year. The U.S. FDA has yet to approve tacrolimus as a treatment for kidney and liver transplants, issuing "approvable" letters on the grounds Astellas submitted insufficient data. The U.S. agency also has declined approval for a heart transplant indication, issuing a "non approvable" letter. Tacrolimus already is approved in Europe, where it is marketed as Advagraf. (Click here for more

You may also be interested in...

Warning Letter Close-Outs – October 2020

The US FDA issued only one device-related close-out letter in October.

Compounding Pharmacies Sue FDA For Conflating Out-Of-State Dispensing And Distribution In MOU

Seven pharmacies have filed a lawsuit against the FDA claiming the agency exceeded its statutory authority in its final standard memorandum of understanding on interstate compounding and that the MOU will have an adverse impact on compounding pharmacies and patients.

What COVID Spotlight Means For Pharma – In Their Own Words

Several experts spoke with Scrip about their take on how the biopharmaceutical industry's efforts to respond to COVID-19 might help industry's image problem. 




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts