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


Eisai, Astellas Experience Delays In Seeking U.S. Drug Approvals

This article was originally published in PharmAsia News

Executive Summary

Eisai and Astellas Pharma separately announced delays in seeking U.S. approval for new drugs, Eisai for more than a year. Eisai said the decision to put off applying for its E7389 (eribulin mesylate) cancer drug would affect the company's long-term business goals. But President Haruo Naito added the company expects to garner more sales at the beginning of its eventual marketing effort as a result. Astellas said it would delay filing for a new formulation of its Prograf (tacrolimus) as a liver transplant immunosuppressant by three months because the U.S. FDA said it needed that time to review the application. (Click here for more

You may also be interested in...

QUOTED. 25 November 2020. Ricki Chase.

The US FDA’s decision to ask on device adverse event reports whether the device involved had been serviced by a third party could help the agency as well as device makers, says Ricki Chase, compliance practice director at Lachman Consultant Services.

US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count

The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.

PhRMA Sues To Block HHS Drug Importation Rule Citing Security, Safety, First Amendment Concerns

Complaint lists host of problems with implementation of the rule that allows states to sponsor programs to import certain prescription drugs from Canada; at least six states have enacted legislation to sponsor these programs.




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