Abstract
Point Biomedical Corp is developing PB-127 (CardioSphere) as an ultrasound imaging agent for assessing myocardial perfusion in patients with coronary artery disease. In January 2006, the company submitted an NDA for the agent; this was accepted for review in February 2006, with a Prescription Drug User Fee Act review and action date of late October 2006. PB-127 is effective for intermittent harmonic power Doppler imaging and may be the first contrast agent to receive FDA approval for myocardial perfusion imaging.
MeSH terms
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Albumins / administration & dosage*
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Albumins / adverse effects
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Albumins / pharmacokinetics
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Animals
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Contrast Media / administration & dosage*
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Contrast Media / adverse effects
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Contrast Media / pharmacokinetics
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Coronary Artery Disease / diagnosis*
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Drug Evaluation, Preclinical
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Humans
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Infusions, Intravenous
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Patents as Topic
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Polyesters / administration & dosage*
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Polyesters / adverse effects
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Polyesters / pharmacokinetics
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Randomized Controlled Trials as Topic
Substances
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Albumins
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Contrast Media
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PB-127 compound
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Polyesters