In Brief: Nycomed's Omniscan
Executive Summary
Nycomed's Omniscan: Imaging agent adds two new indications and a new dosage regimen to its labeling. Under three supplemental NDAs approved Feb. 5, Omniscan (gadodiamide) is indicated for enhancement of magnetic resonance imaging of the internal organs of adults, MRI enhancement of the CNS in children, and for an increase in the cumulative dose from .1 mmol/kg to .3 mmol/kg for MRI of the CNS in adults...