Guerbet announced that the FDA has approved Lipiodol (ethiodized oil) Injection for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). Lipiodol received orphan drug designation in October 2013 for the management of patients with known HCC.

The FDA approval followed shortly after the Agency granted approval to a new manufacturing site for U.S. distribution. Guerbet plans to transition from the temporary importation program pending the availability of the newly approved manufacturing plant.

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Following intra-arterial administration of Lipiodol, ethiodized oil retained in normal hepatic parenchyma is phagocytized by the Kupffer cells of the liver and washed out via the hepatic lymphatic system in about 2 to 4 weeks. In HCC, retention in the liver tumor is prolonged, allowing re-imaging of the tumor for four weeks or longer.

Lipiodol is available as a single 10mL ampoule. Each mL contains 480mg iodine organically combined with ethyl esters of fatty acids of poppy seed oil.

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