Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Astellas’ Once-Daily Tacrolimus Gets Nod From Europe’s CHMP

This article was originally published in The Pink Sheet Daily

Executive Summary

Positive opinion comes after FDA issued a mix of “approvable” and “not approvable” decisions for three transplant claims.

You may also be interested in...



Astellas Tacrolimus Approval Remains At Bay

On heels of second “approvable” letter for kidney transplant rejection, FDA issues another approvable for liver indication.

Astellas Tacrolimus Approval Remains At Bay

On heels of second “approvable” letter for kidney transplant rejection, FDA issues another approvable for liver indication.

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

Extended FDA review period up soon for long-lasting Prograf in liver transplant patients.

Related Content

Topics

UsernamePublicRestriction

Register

PS065684

Ask The Analyst

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

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

Cancel