The U.S. Food and Drug Administration (FDA) has cleared a bulk packaging option for Guerbet's Optiray (ioversal) contrast agent.
The clearance was granted for an Optiray IBP and IBP transfer set. In 2021, the IBP will be available in 500 mL bottles for the Optiray 320 and Optiray 350 concentrations. It can fill single-use syringes, which improves efficiency by minimizing the number of single-dose vials opened without requiring preparation in a laminar flow hood or pharmacy facility, according to the company.
Per labeling, the maximum use time is 12 hours once pierced, Guerbet said.
