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.