Mova/Sandoz Rebut King’s Levothyroxine Lawsuit, Cite Reliance On Own Equivalence Data
This article was originally published in The Pink Sheet Daily
Executive Summary
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.