Generics Bulletin 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

FDA denies petitions on synthetic peptides

Executive Summary

The US Food and Drug Administration (FDA) has simultaneously denied citizen petitions filed by Amneal and Novo Nordisk that sought to block respectively approvals for generic and follow-on versions of Eli Lilly’s Forteo (teriparatide) and the Danish originator’s liraglutide products containing synthetically derived active substances.

You may also be interested in...



Amphastar’s Forteo ANDA Hit With CRL As Wait Goes On

Amphastar will not be receiving approval in 2022 for its proposed generic version of Eli Lilly’s Forteo (teriparatide) peptide for the treatment of osteoporosis, after the FDA told the company it could not issue an approval at this stage.

‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court

In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.

What’s Next? Five Things To Look Out For In October

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB000204

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