Molecular Biosystems Inc. announced Wednesday that the FDAhopes to schedule an advisory committee meeting in June toreview the company's pre-market approval application forAlbunex, an albumen imaging agent.
The company said it received a letter from the FDA on Tuesdaystating that a major portion of its Albunex review had beencompleted and that a meeting of the Radiology Devices panelwas being targeted for some time in June.
Molecular shares (NYSE:MB) gained $1.88 to $23.88 on thenews.
Albunex is a contrast agent for ultrasound imaging derivedfrom human albumin. Molecular's application is for use ofAlbunex in two-dimensional echo cardiography. About 7.2million echo cardiograms are performed annually in the UnitedStates, and the company expects that Albunex would be used in10 percent to 20 percent of these procedures.
Molecular Biosciences plans to file supplements to the PMA forother indications. Albunex is in clinical trials for intra-arterialinjection for use in operating rooms and catheter laboratories,and for radiology applications, said spokeswoman Beth FieldWallace.
Mallinckrodt Medical Inc. has rights to sell and distributeAlbunex in the United States. -- Steve Usdin
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