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Acusphere Inc.
Acusphere Submits New Drug Application for FDA Approval of Imagify
May 18th, 2008
Acusphere Inc. (NASDAQ: ACUS) announced the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. The 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). Imagify is the first ultrasound imaging agent designed to...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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