Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Astellas’ Once-Daily Tacrolimus Again “Approvable” For Kidney Transplant Patients

This article was originally published in PharmAsia News

Executive Summary

Astellas Pharma received a second U.S. FDA "approvable" letter for use of its long-lasting immunosuppressant FK506 in kidney transplant patients, the company said March 14.

You may also be interested in...



Astellas Tacrolimus Approval Remains At Bay

Astellas Pharma has met with another snag in its attempt to win FDA approval for the once-daily version of its immunosuppressant Prograf (tacrolimus) with receipt of an FDA "approvable" letter for prophylaxis of organ rejection in liver transplant patients

Astellas Tacrolimus Approval Remains At Bay

Astellas Pharma has met with another snag in its attempt to win FDA approval for the once-daily version of its immunosuppressant Prograf (tacrolimus) with receipt of an FDA "approvable" letter for prophylaxis of organ rejection in liver transplant patients

Astellas Backed By Full Pipeline To Battle Japan Price Controls and Slow Approvals In U.S.

Astellas' user fee date for immunosuppressant Prograf MR (tacrolimus) NDA pending at the U.S. FDA has been extended for another three months, the company told a third quarter earnings call Feb.1 at its headquarters in Tokyo

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

SC067918

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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

Cancel