Du Pont Merck Pharmaceuticalsis poised to become the second company with a brain SPECT agenton the U.S. market. The Food and Drug Administration has sentDu Pont an "approvable" letter for Neurolite, its technetium-taggedbrain imaging agent.
Du Pont Merck Pharmaceuticalsis poised to become the second company with a brain SPECT agenton the U.S. market. The Food and Drug Administration has sentDu Pont an "approvable" letter for Neurolite, its technetium-taggedbrain imaging agent.
Neurolite is indicated for brain perfusion studies in strokepatients. An FDA advisory committee recommended Neurolite forapproval last year (SCAN 6/30/93). Final FDA approval will begiven upon mutual agreement of labeling and phase-four studies,according to the company. Neurolite has regulatory approval inJapan and several European countries.
Neurolite's arrival would double the number of commerciallyavailable brain SPECT agents in the U.S. Amersham's technetium-labeledCeretec is currently the only brain SPECT agent being activelymarketed.
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.