MBI passes milestone in contrast effort
The Food and Drug Administrationhas granted Molecular Biosystems (MBI) an "approvable letter"for its Albunex ultrasound contrast agent, the San Diego pharmaceuticaldeveloper reported last week. The letter outlines some final requeststhat, once
The Food and Drug Administrationhas granted Molecular Biosystems (MBI) an "approvable letter"for its Albunex ultrasound contrast agent, the San Diego pharmaceuticaldeveloper reported last week. The letter outlines some final requeststhat, once met, will mean that the agent fulfills all requirementsfor final FDA approval. If approved, Albunex would be the firstultrasound imaging agent cleared for commercialization in theU.S.
MBI indicated that most of the requests were minor, relatingto labeling and other specifications, and the firm will respondto them "in the next few days." The agency has alsoasked that MBI conduct postapproval studies on any adverse deviceeffects (ADEs) of Albunex. MBI indicated that all ADEs of Albunexfound during clinical trials were minor and resolved without treatment.
