King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss
This article was originally published in The Pink Sheet Daily
Executive Summary
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.