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FDA NOTIFIES MOLECULAR BIOSYSTEMS

 FDA NOTIFIES MOLECULAR BIOSYSTEMS
 SAN DIEGO, April 8 /PRNewswire/ -- Molecular Biosystems Inc. (MBI)


(NYSE: MB) announced today that it has received written notification from the United States Food and Drug Administration ("FDA") that the FDA's Center for Devices and Radiological Health has completed a major portion of the review of (MBI's) premarket approval application ("PMA") for Albunex(R) and that the FDA is currently attempting to schedule a meeting of the Radiology Devices Panel for June 1992, at which (MBI's) PMA will be reviewed.
 The advisory panel meeting is the final component of the FDA premarket review process for medical devices such as Albunex.
 The company received the written notification yesterday in a brief letter, dated April 3, which noted that the company had addressed the issues raised by the FDA during the review process to date, and that the FDA staff does not have any questions at the present time. The letter also stated that review of the PMA would continue and that further information might be required.
 "We are extremely pleased that the Albunex PMA has reached this important regulatory milestone," commented Kenneth J. Widder, M.D., MBI's chairman and chief executive officer. "We have been actively preparing for the company's presentation to the Radiology Devices Panel and are looking forward to the opportunity to answer any further questions regarding Albunex which may arise at the panel meeting," he further stated.
 Albunex, a contrast agent for use with ultrasound, is MBI's flagship product. Currently, there are no contrast agents for use with ultrasound on the market in the United States today.
 Molecular Biosystems Inc., based in San Diego, is a leader in the development and manufacturing of contrast agents for medical imaging, including ultrasound and magnetic resonance imaging.
 -0- 4/8/92
 /CONTACT: Beth Field Wallace (investors) of Molecular Biosystems, 619-452-0681/
 (MB) CO: Molecular Biosystems Inc. ST: California IN: MTC SU:


DM-JL -- SD003 -- 6069 04/08/92 08:31 EDT
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Publication:PR Newswire
Date:Apr 8, 1992
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