April 18, 2014 — Guerbet announced that Lipiodol was approved by the U.S. Food and Drug Administration (FDA), 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 the United States estimated to affect in the range of 35,000 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 U.S. are in line with our company mission of offering reliable and innovative solutions to improve the efficacy of interventional radiology procedures," said Massimo Carrara, Guerbet U.S. general manager.
This approval was received shortly after FDA granted approval to a new site to manufacture Lipiodol, validated for U.S. distribution only (Jubilant HollisterStier, Canada). Guerbet plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant will be available in the U.S.
Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. It is indicated for hysterosalpingography in adults, lymphography in adults and children, and selective hepatic intra-arterial use for imaging tumors in adults with known HCC.
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