Du Pont's Neurolite is `approvable'
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.
