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

KV’s Suit Against FDA Is Revived By Thiopental Ruling, Compounding Law

This article was originally published in The Pink Sheet Daily

Executive Summary

Makena legal strategy benefits from halt on importation of unapproved execution drug.

You may also be interested in...



Marathon Gets Long-Known Duchenne Treatment On-Label, But Will Payers Respond?

Steroid treatment like Emflaza is considered standard of care and availability of other products may make payer discussions difficult.

KV Emerging From Bankruptcy As Makena Sales Pick Up Steam

KV clears major hurdle as court okays its chapter 11 reorganization plan, which provides for payment of $23.4 million owed under 2010 Department of Justice settlement and $231.4 million for senior notes; firm’s future remains tied to Makena.

FDA Compounding Statements Beyond Judicial Review; Court Tosses Makena Suit

The agency’s public statements about compounded versions of the pre-term birth drug are exempt from judicial review under a 1985 Supreme Court decision, U.S. Judge Amy Berman Jackson said.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076359

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