Guerbet Receives FDA's Drug Shortage Assistance Award: Recognized for contributions to address a shortage of Ethiodol (ethiodized oil) injection

PRINCETON N.J., Sept. 29, 2014 /PRNewswire/ -- Guerbet, a pioneer in the field of contrast agents for medical imaging, has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its assistance in preventing or alleviating a drug shortage.

Guerbet is being recognized for its efforts related to the shortage of Ethiodol (ethiodized oil) injection, including acquiring the new drug application, submitting several post-approval supplements to restart manufacturing with acceptable compliance records, and to market the product for a well-known and medically necessary indication in the United States. These actions by Guerbet resolved a critical drug shortage affecting patients with cancer.

Ethiodol (ethiodized oil) injection, now under the tradename of Lipiodol®, is an oil-based radiopaque contrast agent used to image tumors in patients with certain types of cancer.

Through the Drug Shortage Assistance Award program, FDA recognizes companies for making a substantial contribution to preventing or alleviating a critical drug shortage. This award also recognizes companies for their commitment to public health, as well as a commitment to quality manufacturing.

"We are pleased that the FDA recognizes our commitment to ensuring U.S. patients have access to the medications they need," commented Yves L'Epine, CEO of Guerbet.

Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013.

There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.

FDA is committed to working with companies, like Guerbet, to prevent and mitigate drug shortages.

About Guerbet

A pioneer in the field of contrast agents with more than 80 years of experience, Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide. As such it has a complete offering of contrast products for X-ray and MRI and for Interventional Radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients. To promote the discovery of new products and assure future growth, Guerbet devotes significant resources to research and development every year (approximately 10% of sales). Guerbet (GBT) is listed on the NYSE Euronext Paris (Eurolist Segment B – Mid Caps) and had sales of €390 million in 2013 with a total workforce of 1,485 employees. For additional information about Guerbet please go to www.guerbet.com.

This press release may contain forward-looking statements based on current assumptions and forecasts made by Guerbet Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performances of the company and the estimates given here. These factors include those discussed in Guerbet's public reports which are available on the Guerbet website at www.guerbet.com. The company assumes no liability whatsoever to update these forward-looking-statements or to conform them to future events or developments.

SOURCE Guerbet LLC, USA