FDA advisory panel meeting scheduled for FS069.SAN DIEGO--(BUSINESS WIRE)--Jan. 9, 1997--Molecular Biosystems Inc. (NYSE NYSE See: New York Stock Exchange :MB) (MBI) Thursday announced that the company received notification from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) that it has scheduled an advisory panel review for MBI's second generation ultrasound contrast agent, FS069, on Feb. 24, 1997. The Radiology Device Advisory Panel will review the use of FS069 for use with 2-D echocardiography Echocardiography Definition Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and (ultrasound of the heart). This is the first in a series of cardiovascular and radiology indications for FS069 for which MBI will be seeking approval from the FDA. The indications will include myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). perfusion and enhancement of liver and kidney ultrasound imaging. Following FDA approval, Mallinckrodt Inc. (NYSE:MKG) will market and sell FS069 in the United States. Molecular Biosystems, based in San Diego, is a leader in the development and manufacture of ultrasound contrast agents for medical imaging. ALBUNEX, the first FDA approved ultrasound imaging agent, is currently marketed in the United States by Mallinckrodt Inc. CONTACT: Molecular Biosystems Inc., San Diego Gerard A. Wills/Stephen F. Keane, 619/824-2212 |
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