FDA Approves GADOBUTROL — Zydus Pharmaceuticals USA Inc.

The FDA has approved the previously withdrawn version of GADOBUTROL from Zydus Pharmaceuticals USA Inc., increasing competition in the market for this MRI contrast agent and potentially pressuring pricing in the space before greater patent cliffs loom later this year. The regulatory green light is expected to benefit patients by broadening supply options for intravenous gadolinium-based agents.