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Friday, April 11, 2014

Guerbet : FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma

Guerbet
FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma (HCC) 

Guerbet LLC, USA (April 10, 2014) Princeton (NJ), Guerbet, a pioneer in the field of contrast agents for medical imaging announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). HCC is the most common primary liver tumor and represents the third-leading cause of cancer-related death in the world, with prevalence in US estimated to affect in the range of 35,000 U.S. patients in 2013.

As previously announced in October 2013, Lipiodol has received an orphan-drug designation for management of patients with known HCC.

"Guerbet is pleased to have been granted approval for use of Lipiodol in patients with known HCC. This product has been supplied during the past three years under a temporary importation program. Guerbet’s efforts to improve the availability of Lipiodol in the USA are in line with our company mission offering reliable and innovative solutions to improve the efficacy of Interventional Radiology procedures”, commented Massimo Carrara, Guerbet US General Manager... [PDF] Guerbet's press Release - PDF Communiqué de Presse Guerbet -