KV’s Suit Against FDA Is Revived By Thiopental Ruling, Compounding Law
This article was originally published in The Pink Sheet Daily
Makena legal strategy benefits from halt on importation of unapproved execution drug.
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Steroid treatment like Emflaza is considered standard of care and availability of other products may make payer discussions difficult.
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.
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.