DuPont submits MAA for Definity
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.
EMEAs review arm, the Committee for Proprietary Medicinal Products (CPMP), will examine the North Billerica, MA, companys 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).