An abbreviated new drug application for a generic version of DaTscan (Ioflupane I 123 Injection) with the US Food and Drug Administration (FDA) was submitted by Curium. The company has been granted priority review by the FDA, which has set a Generic Drug User Fee Act (GDUFA) goal date in Q4 2021. Ioflupane I 123 Injection is a SPECT brain imaging agent used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes.
“Curium is committed to developing generic medications for clinicians and patients at a lower cost,” said Michael Patterson, Curium’s North American VP of Marketing. “Our weekend manufacturing across our portfolio and logistical capabilities also afford the market the opportunity to scan patients starting in the beginning of the week and early in the morning.”
“Our ability to produce radiopharmaceuticals at a central location and distribute them to nuclear pharmacies, hospitals, and imaging centers across the U.S. is a key factor in helping us meet the demands of our customers,” said Andy Farrow, VP of Sales, North America. “Curium has an extensive distribution network that allows us to reach U.S. customers with early morning delivery, which provides flexibility to physicians and patients.”Back To Top
Generic Version for DaTscan Filed in the US. Appl Radiol.