Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Acusphere has submitted a new drug application to the FDA for approval to market its lead product candidate, Imagify.
Subscribe to our email newsletter
Imagify is an ultrasound imaging agent for the detection of coronary artery disease. The new drug application (NDA) includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, Ramp-1 and Ramp-2 (real-time assessment of myocardial perfusion).
The FDA has 60 days after receipt of the NDA to review and determine if the application is sufficiently complete to permit a substantive review and meets the threshold for filing.
Sherri Oberg, Acusphere’s president and CEO, said: “We believe Imagify offers important benefits in the detection of heart disease, including lower costs, speedier results and greater accessibility without exposure to radiation, and we are eager to bring those benefits to millions of patients and clinicians in the US.”