Guerbet (GBT), the contrast agent specialist for medical imaging, today announced that it had received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing plant for Lipiodol® (ethiodized oil) Injection, in Montreal, Canada.
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 for the U.S. patients. During this interim period, Guerbet, in conjunction with the FDA, has maintained a temporary importation of Lipiodol®, ethyl esters of iodized fatty acids of poppy seed oil, to the United States market. Lipiodol® contains the same drug components as Ethiodol®.
"After maintaining the product supply through a temporary importation program authorized by FDA, we are proud to add the United States to the list of countries where Lipiodol® is now available from an FDA approved manufacturing site," said Yves L'Epine, CEO of the Guerbet Group.
Massimo Carrara, General Manager of Guerbet LLC in USA also commented, "The approval of the new manufacturing site represents the ongoing commitment of Guerbet to consistently supply American healthcare professionals and their patients with ethiodized oil."
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.
For more information about the temporary importation program, please see the Dear Healthcare Professional Letter.
Indications and Usage
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 10mL ampoule.
Important Safety Information
Lipiodol® is contraindicated in:
Patients hypersensitive to Iodine.
Lymphography in patients with a right to left cardiac shunt, in patients with advanced pulmonary disease, especially those with alveolar-capillary block, and in patients who have had radiotherapy to the lungs.
Hysterosalpingography during intrauterine pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis in the presence of intrauterine bleeding, in the immediate pre-or postmenstrual phase, or within 30 days of curettage or conization.
Warnings and Precautions
Lipiodol® may cause pulmonary embolization, hypersensitivity reactions and hyperthyroidism. The use of intralymphatic Lipiodol® presents a significant risk in patients with preexisting pulmonary disease characterized by a decrease in pulmonary diffusing capacity and/or pulmonary blood flow. This was noticed more frequently when excessive amounts of Lipiodol® have been injected, in the presence of marked lymphatic obstruction or through accidental intravenous injection.
Most Common Adverse Reactions
The most common adverse reactions are hypersensitivity reactions, foreign body reactions, and exacerbation of pelvic inflammatory disease, although infrequent. The occasional observation of pulmonary Lipiodol® embolization several hours after injection has been reported.