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

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.

You may also be interested in...



King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss

A D.C. federal judge declines to stay or temporarily revoke FDA approval of supplemental NDAs allowing Alara’s Levo-T and Jerome Stevens’ Unithroid to claim equivalence to Levoxyl. Mylan also is protesting FDA approval of the supplemental NDAs because the company believes it is entitled to 180-day generic exclusivity for Levoxyl.

King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss

A D.C. federal judge declines to stay or temporarily revoke FDA approval of supplemental NDAs allowing Alara’s Levo-T and Jerome Stevens’ Unithroid to claim equivalence to Levoxyl. Mylan also is protesting FDA approval of the supplemental NDAs because the company believes it is entitled to 180-day generic exclusivity for Levoxyl.

Mova/Sandoz Rebut King’s Levothyroxine Lawsuit, Cite Reliance On Own Equivalence Data

Certification to a King patent listed in the “Orange Book” was unnecessary because Mova’s sNDA approval was based on its own bioequivalence data and FDA advised the company it did not need to certify to the patent, Mova says.

Topics

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