February 20, 2014 — Guerbet, a contrast agent specialist for medical imaging, received U.S. Food and Drug Administration (FDA) approval for a manufacturing plant for Lipiodol (ethiodized oil) Injection, in Montreal, Canada.
Lipiodol is indicated for use as a radio-opaque medium for lymphography and hysterosalpingography. It contains 475 mg Iodine/mL organically combined with ethyl esters of the fatty acids (primarily as ethyl monoiodostearate and ethyl diiodostearate) of poppyseed oil. Lipiodol is supplied in a box of one 10 mL ampoule.
FDA approval provides clinicians with additional resource for patient care management.
Guerbet has acquired the Ethiodol NDA effective May 7, 2010 and since then has been working with the FDA to resume manufacturing of Ethiodol to ensure continued availability to U.S. patients. During this interim period, Guerbet, in conjunction with the FDA, maintained a temporary importation of Lipiodol. Lipiodol contains the same drug components as Ethiodol.
Guerbet plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant is available in the United States.
For more information: guerbet.com