King Sues FDA Over Levoxyl Bioequivalence Claims For Levo-T, Unithroid
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency should not have accepted supplemental NDAs that lacked Paragraph IV certifications to a King patent, the company says. King is asking the court to revoke approvals for Jerome Stevens and Mova/Sandoz and to enjoin FDA from approving other 505(b)(2) supplements claiming equivalence to Levoxyl.
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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.
King Denied Injunction In Levothyroxine Suit Against FDA; Mylan Faces Exclusivity Loss
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.
Mova/Sandoz Rebut King’s Levothyroxine Lawsuit, Cite Reliance On Own Equivalence Data
Certification to a King patent listed in the “Orange Book” was unnecessary because Mova’s sNDA approval was based on its own bioequivalence data and FDA advised the company it did not need to certify to the patent, Mova says.