FDA accepts Acusphere application for coronary artery disease imaging agent
The FDA has accepted Acusphere’s new drug application (NDA) for approval review to market its lead product candidate, Imagify (Perflubutane Polymer Microspheres for Injectable Suspension).
Imagify is an ultrasound imaging agent for the detection of coronary artery disease, according to the Watertown, Mass.-based Acusphere.
The company said its 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 acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing, Acusphere said. With a standard review, under the FDA Prescription Drug User Fee Act, the target action date is 10 months from the submission date, or Feb. 28, 2009.
Imagify is an ultrasound imaging agent for the detection of coronary artery disease, according to the Watertown, Mass.-based Acusphere.
The company said its 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 acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing, Acusphere said. With a standard review, under the FDA Prescription Drug User Fee Act, the target action date is 10 months from the submission date, or Feb. 28, 2009.