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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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.