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MOLECULAR BIOSYSTEMS RECEIVES FDA LETTER REGARDING ALBUNEX(R) PMA AMENDMENT

 SAN DIEGO, Nov. 19 ~PRNewswire~ -- Molecular Biosystems Inc. (NYSE: MB) (MBI) announced today that it received a letter from the U.S. Food and Drug Administration (FDA) advising the company that its Pre-Market Approval application (PMA) for its cardiac ultrasound imaging agent, Albunex(R), must be amended to incorporate certain additional information in order to render the PMA approvable by the FDA.
 MBI already possesses the necessary information, has initiated the required actions, and anticipates prompt submission of the PMA amendment. The company is confident that the matters raised in the letter will not affect approval of Albunex by the FDA. However, as a result, the FDA's final decision regarding approval will likely be delayed by at least several months.
 On July 14, 1992, the FDA's Radiologic Devices Advisory Panel ("the panel") unanimously recommended that Albunex be approved for sale and use based on the safety and efficacy information contained in the PMA and other information presented at the panel meeting. As is customary, the FDA staff has continued its review of the PMA prior to final FDA action.
 In the letter dated Nov. 18, 1992, from the Office of Device Evaluation (ODE) of the FDA's Center for Devices and Radiological Health dated Nov. 18, 1992, the ODE advised the company that the PMA is not currently approvable, and described the contents of an amendment required in order to render it approvable. The letter is the first written communication from the FDA regarding the PMA since the July 1992 panel meeting. The information and actions recommended by the ODE fall into three categories:
 -- The ODE incorporates the panel recommendations relating to labeling and post-approval monitoring of patients. The company has been actively preparing to meet these recommendations since the panel meeting;
 -- The ODE requests that the PMA be updated with recent safety and efficacy data collected by MBI. This information is readily available to the company and will be provided as requested; and
 -- The ODE requests certain information with respect to the manufacturing process described in the PMA. The company is prepared to address the issues raised by the ODE with respect to that manufacturing process.
 The company believes that it possesses all of the information necessary to respond satisfactorily to all of the issues raised by the ODE letter. The letter does not request that any additional pre- approval studies be conducted. The company plans to submit the recommended amendments to the PMA expeditiously.
 The company remains confident that Albunex will be approved by the FDA. However, because the FDA possesses broad discretion in the pre-market approval process, the company cannot predict when the FDA's final decision regarding approval will be made.
 Once approved, Albunex will be marketed and distributed worldwide by MBI's partners, including Mallinckrodt Medical Inc. (IMCERA Group (NYSE: IMA)) in the United States, Shionogi & Co. Ltd. in Japan and Hafslund Nycomed AS (NYSE: HN) in Europe. MBI's shares are listed on the New York Stock Exchange under the symbol "MB."
 -0- 11~19~92
 ~CONTACT: Sherry L. Mesman, CFO of Molecular Biosystems, 619-452-0681, ext. 2212~
 (MB)


CO: Molecular Biosystems Inc. ST: California IN: MTC SU: PDT

BP-JB -- SD004 -- 3028 11~19~92 15:12 EST
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Publication:PR Newswire
Date:Nov 19, 1992
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