DuPont submits MAA for Definity

Article

In its continued effort to bring ultrasound contrast agent Definity to market, DuPont Pharmaceuticals has filed a marketing authorization application (MAA) for the agent with the European Medicines Evaluation Agency (EMEA). The application is based on

In its continued effort to bring ultrasound contrast agent Definity to market, DuPont Pharmaceuticals has filed a marketing authorization application (MAA) for the agent with the European Medicines Evaluation Agency (EMEA). The application is based on seven multicenter phase III clinical trials that included 610 patients at 52 U.S. medical centers and covers the use of Definity for contrast-enhanced ultrasound imaging of the heart and abdomen.

EMEA’s review arm, the Committee for Proprietary Medicinal Products (CPMP), will examine the North Billerica, MA, company’s application. If cleared by the CPMP, DuPont will be able to sell Definity in all of the European Union countries. DuPont has also filed a new drug submission (NDS) for Definity with the Health Protection Branch of Health Canada, and, in 1998, filed an NDA with the Food and Drug Administration (SCAN 12/16/98).

Recent Videos
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Can AI Assessment of Longitudinal MRI Scans Improve Prediction for Pediatric Glioma Recurrence?
A Closer Look at MRI-Guided Adaptive Radiotherapy for Monitoring and Treating Glioblastomas
Incorporating CT Colonography into Radiology Practice
What New Research Reveals About Computed Tomography and Radiation-Induced Cancer Risk
What New Interventional Radiology Research Reveals About Treatment for Breast Cancer Liver Metastases
New Mammography Studies Assess Image-Based AI Risk Models and Breast Arterial Calcification Detection
Can Deep Learning Provide a CT-Less Alternative for Attenuation Compensation with SPECT MPI?
Related Content
© 2025 MJH Life Sciences

All rights reserved.