FDA clears Bayer's Gadavist imaging bulk package

2019 12 19 17 46 9582 Bayer Rsna 2019 400

The U.S. Food and Drug Administration (FDA) has approved a bulk packaging option for Bayer's Gadavist (gadobutrol) MRI contrast agent.

The contrast agent will be available in two sizes: 30 mL and 65 mL, which allows for weight-based dosing with a 24-hour stand time for multipatient dosing, according to the firm.

In other Bayer news, the FDA also cleared the firm's Medrad imaging bulk package transfer spike indicated for the transfer of Gadavist contrast media as supplied in the imaging bulk package presentation.

Compared with single-use bottles, the bulk package provides the opportunity for more complete contrast use and less contrast and vial waste, Bayer said.

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