A German pharmaceutical company announced the United States Food and Drug Administration has accepted its application for a gadolinium-based contrast agents.
Bayer Schering Pharma AG says the FDA has approved a new gadolinium-based MRI contrast agent called Gadovist, which is a non ionic agent. Gadovist has not yet been approved by the administration; the FDA has merely accepted Bayer's product application.
"If approved by the FDA, Gadovist 1.0 would compliment our portfolio of contrast agents in the United States," said Hans Maier, Head of the Diagnostic Imaging business unit at Bayer Schering Pharma. "This submission to the FDA is an important milestone for us."
Gadolinium-based MRI agents, like Gadovist, have been linked to severe health effects in people with kidney problems, most commonly the development of nephrogenic systemic fibrosis.
If you have developed NSF because of gadolinium-based agents, you may be eligible for compensation. Contact a
gadolinium lawyer of Williams Kherkher by calling 800-761-3187.