March 15, 2011
Not intended for U.S. Media

U.S. FDA Approves Bayer's Gadobutrol Injection for MRI of the Central Nervous System

Berlin, March 15, 2011 - Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved Bayer's gadobutrol injection GadavistTM (gadobutrol), a 1.0 molar macrocyclic gadolinium-based contrast agent (GBCA) for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children age two and older to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS). GadavistTM is known as Gadovist® outside the U.S. and is approved in over 60 countries.

"We are very happy to offer gadobutrol injection to U.S. healthcare providers, an important new option for contrast-enhanced MRI of the CNS," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. Our MR contrast agents are some of the most widely used today, and Bayer is proud to be a world leader in diagnostic imaging."

MRI has been used by physicians for more than 25 years to create detailed images of the human anatomy. Contrast agents are often used to better visualize anatomic structures and pathologies.

About the U.S, Clinical Phase III trials
Data submitted by Bayer for approval included results from two Phase III studies that confirmed the efficacy and safety of 1.0 molar gadobutrol injection in contrast enhanced MRI of the CNS. The first Phase III study compared the efficacy of combined gadobutrol-enhanced images plus unenhanced (without injection of contrast agent) images to unenhanced images alone. The second Phase III study used a crossover design with an active control, gadoteridol, to also compare the efficacy of the combined gadobutrol-enhanced plus unenhanced images to unenhanced images alone, as well as to confirm noninferiority of combined gadobutrol imaging versus combined gadoteridol imaging.

To learn more about imaging techniques, please visit:

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55.700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at

Find more information at

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