Pink Sheet 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

King Sues FDA Over Levoxyl Bioequivalence Claims For Levo-T, Unithroid

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency should not have accepted supplemental NDAs that lacked Paragraph IV certifications to a King patent, the company says. King is asking the court to revoke approvals for Jerome Stevens and Mova/Sandoz and to enjoin FDA from approving other 505(b)(2) supplements claiming equivalence to Levoxyl.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059834

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