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Guerbet SA announces FDA approves Lipiodol (Ethiodized Oil) injection for imaging of tumors in adults

Thursday, 10 Apr 2014 12:13pm EDT 

Guerbet SA:Lipiodol was approved by US Food and Drug Administration pursuant to section 505(b)(2) of 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 most common primary liver tumor and represents third-leading cause of cancer-related death in world( [1] ), with prevalence in U.S. estimated to affect in range of 35,000 U.S. patients in 2013.As previously announced in October 2013, Lipiodol has receive orphan-drug designation for management of patients with known HCC.This approval was received shortly after FDA granted approval to new site to manufacture Lipiodol, validated for U.S. distribution only (Jubilant HollisterStier, Canada). 

Company Quote

0.05 +0.15%
19 Dec 2014