French contrast agent developer Guerbet has received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing plant for Lipiodol (ethiodized oil) in Montreal.
Guerbet has been maintaining the product supply of Lipiodol in the U.S. through a temporary importation program authorized by the FDA, the firm said. With the new plant, Lipiodol will now be available from an FDA-approved manufacturing site.
Guerbet said it plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant is available.
Lipiodol is indicated for use as a radio-opaque medium for lymphography and hysterosalpingography, according to the company.
