Printer Friendly

MOLECULAR BIOSYSTEMS INC. SUBMITS PMA AMENDMENT TO FDA

 SAN DIEGO, Dec. 31 /PRNewswire/ -- Molecular Biosystems Inc. (NYSE: MB) ("MBI") announced today that it has submitted for filing with the U.S. Food and Drug Administration ("FDA") an amendment to its Pre-Market Approval application ("PMA") for its ultrasound imaging agent, Albunex(R). This filing is in response to the FDA's Nov. 18, 1992, request for certain additional information regarding Albunex and its manufacture.
 On July 14, 1992, the Radiologic Devices Advisory Panel of the FDA unanimously recommended that Albunex be approved for sale and use. In a letter of Nov. 18, 1992, the FDA staff requested certain additional information, which MBI submitted yesterday in the form of an amendment to the PMA. The Nov. 18 letter was described in MBI's news release of Nov. 19, 1992.
 By statute, the FDA staff has 180 days from the date of filing to review the PMA amendment. While the company is hopeful that the FDA staff will act promptly, it cautions that the FDA has wide discretion in its review process, and that the timing and nature of the FDA's response cannot be predicted with certainty.
 Molecular Biosystems Inc., based in San Diego, is a leader in the development of contrast agents for medical imaging, including ultrasound, MRI and CT. Once approved, its flagship product, 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- 12/31/92
 /CONTACT: Beth Field Wallace, corporate communications, or Vincent A. Frank, president and COO of Molecular Biosystems, 619-452-0681, ext. 2212/
 (MB IMA HN)


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

JB-KJ -- SD001 -- 0830 12/31/92 09:00 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 31, 1992
Words:306
Previous Article:MEDQUIST PLANS APOTHECARY CLOSING
Next Article:ADVANCED TISSUE SCIENCES AND CELL GENESYS TO COLLABORATE IN DEVELOPING A UNIVERSAL 'FULL-THICKNESS' SKIN TRANSPLANT PRODUCT
Topics:


Related Articles
THERMO CARDIOSYSTEMS SUBMITS CARDIAC-ASSIST DEVICE FOR FDA REVIEW
FDA ACCEPTS THERMO CARDIOSYSTEMS' HEARTMATE PMA APPLICATION FOR FILING AND FORMAL REVIEW
FDA ADVISORY PANEL MEETING SCHEDULED FOR ALBUNEX
EPITOPE RESPONDS TO UNUSUAL STOCK ACTIVITY
EPITOPE'S ORASURE PREMARKET APPROVAL APPLICATION SCHEDULED FOR REVIEW BY FDA ADVISORY PANEL
CARDIOPULMONICS REPORTS PMA SUBMISSION
MBI SUED BY COMPETITOR OVER ORAL AGENT
FDA REQUIRES CARDIOPULMONICS TO AMEND PMA SUBMISSION BEFORE FILING
AutoCyte Announces Status of PREP PMA
Food And Drug Administration Requests No Additional Clinical Trials For AutoCyte PREP

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters