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

The ABCs Of Accelerated Approval Withdrawals

Executive Summary

At least six accelerated approval drugs have either been withdrawn or had indications revoked because confirmatory studies were not completed or failed to verify clinical benefit – including Avastin, Bexxar and Celebrex.

You may also be interested in...



Keeping Track: Bad News For Bristol And Lilly, Good News For TG Therapeutics

The latest drug development news and highlights from our US FDA Performance Tracker.

Product Withdrawal Can Be As Hard As Approval: Luveris' 4-Year Journey Ends

EMD Serono had not marketed the infertility treatment in US since 2012, when it first asked FDA to withdraw application; company was unable to complete confirmatory trial required under accelerated approval.

“Not Another Avastin,” FDA Panel Warns Genentech At Perjeta Review

Under questioning from FDA’s Richard Pazdur, VP Sandra Horning says company would be willing to withdraw pertuzumab’s neoadjuvant indication if results from ongoing adjuvant study are “clearly negative”; advisory committee members say they expect sponsor to bow out more gracefully than it did in the fight over bevacizumab’s breast cancer claim.

Topics

Related Companies

UsernamePublicRestriction

Register

PS142351

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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