The US Food and Drug Administration (FDA) has approved Guerbet’s Lipiodol (ethiodized oil) injection for hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC), according to a press release from the manufacturer.
In October 2013, the FDA granted Lipiodol Orphan Drug Designation for management of patients with HCC.
For the past 3 years, Lipiodol has been supplied via a temporary importation program. The FDA, however, recently approved a new manufacturing site for US distribution, and Guerbet plans to transition from the importation program once product from the newly approved manufacturing site is available in the US, according to information in the release.
Lipiodol is contraindicated in patients with a hypersensitivity to the agent, hyperthyroidism, traumatic injuries, or recent hemorrhage or bleeding.
“The additional indication approved by FDA is a major milestone on the ambitious approach taken by the company to keep the product accessible for US patients to assist in the management of this devastating disease,” Corina Harper, Guerbet Director of North America Medical and Regulatory Affairs, said in the release.
“We are pleased to receive FDA authorization which assures continuous accessibility to this drug to many HCC patients across America”, said Corina Harper, Guerbet Director of North America Medical and Regulatory Affairs.”