FDA Approves Imaging Agent for Liver Cancer

Nick Mulcahy

Disclosures

April 14, 2014

The US Food and Drug Administration (FDA) has approved Lipiodol for selective hepatic intra-arterial use when imaging tumors in adults with known hepatocellular carcinoma (HCC), according to a statement from Guerbet, the company that owns and distributes the agent.

The product, also known as Lipiodol Ultra-Fluide, consists of ethyl esters of iodized fatty acids from poppy seed oil.

The approval was made under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which means that the applicant, Guerbet, relied on data in its application that were based on studies "not conducted by or for the applicant and for which the applicant has not obtained a right of reference."

Lipiodol has been available in the United States for 3 years under a temporary importation program, according to the company.

The emergency importation was needed because a similar product, Ethiodol (Savage Laboratories/Nycomed), was in critical shortage in the United States, according to a 2013 letter from the company to healthcare professionals.

This new FDA approval comes after the FDA recently granted Jubilant HollisterStier approval to manufacture Lipiodol in a Canadian plant for distribution in the United States only.

"The additional indication approved by FDA is a major milestone in the ambitious approach taken by the company to keep the product accessible for US patients to assist in the management of this devastating disease. We are pleased to receive FDA authorization, which ensures continuous accessibility to this drug for many HCC patients across America," said Corina Harper, director of North America Medical and Regulatory Affairs at Guerbet, in a press statement.

Guerbet will transition from the temporary importation program as soon as the newly approved manufacturing plant can provide product, according to a press report.

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