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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.
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