Generics Bulletin 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

Teva Pushes CGRP Timeline Back To End Of 2018

Executive Summary

Management said the migraine drug fremanezumab could launch in the US by the end of the year following discussions with the US FDA. The June timeline has been delayed by a Celltrion manufacturing issue.

You may also be interested in...



Teva On Tenterhooks Over Fremanezumab As Celltrion Gets CRLs

The FDA is not approving two biosimilars from Teva and Celltrion over concerns about the latter's facility, leading to more speculation that approval of the Israeli firm's potential migraine blockbuster, manufactured at the same plant, may be delayed.

Sandoz's Less Frequently Dosed Copaxone Generic Glatopa Hits Teva Two Months Early

Teva said its 2018 revenue guidance reflected an April launch for the 40 mg dose of Glatopa, but Sandoz and partner Momenta announced FDA approval and the US launch of their less frequently administered Copaxone generic on Feb. 13.

Bad News Teva Really Doesn't Need: A Potential Delay For Fremanezumab

One of Teva's few bright spots is its leading position in the big new commercial opportunity for migraine, but its CGRP drug fremanezumab could now be delayed by an issue at third-party manufacturer Celltrion.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB001591

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