Nuclear medicine firm Curium Pharma plans to submit an abbreviated new drug application (NDA) for a generic version of DaTscan in the U.S.
DaTscan, ioflupane iodine-123, is a SPECT brain imaging agent designed to help evaluate adult patients with suspected parkinsonian syndromes. If approved, Curium expects to launch the product as early as the end of 2020.
GE Healthcare developed DaTscan earlier this decade for use with SPECT to image the striatum of the brain in patients with conditions that include Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy. The imaging agent is cleared by the U.S. Food and Drug Administration and last year received marketing clearance from Health Canada.
