Contrast agent manufacturer Guerbet has received recognition from the U.S. Food and Drug Administration (FDA) for alleviating a drug shortage of its Ethiodol (ethiodized oil) contrast agent.
The FDA presents the Drug Shortage Assistance Award to companies that make a substantial contribution to preventing or alleviating a critical drug shortage. The award also recognizes companies for their commitment to public health, as well as a commitment to quality manufacturing.
To rectify a shortage of Ethiodol, Guerbet acquired a new drug application, submitted postapproval supplements to restart manufacturing with acceptable compliance records, and marketed the product for a well-known and medically necessary indication in the U.S.
Ethiodol, now under the trade name Lipiodol, is an oil-based radiopaque contrast agent used to image tumors in patients with certain types of cancer.
