4th May 2021
Curium Announces Filing of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S.
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(St. Louis, MO – May 4, 2021) – Curium announced today that it submitted an abbreviated new drug application for a generic version of DaTscan (Ioflupane I 123 Injection) with the U.S. Food and Drug Administration (FDA). Curium 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 single-photon emission computed tomography (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 V.P. 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, V.P. 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.”
DaTscan™ is a registered trademark of GE Healthcare Limited.
Curium is the world’s largest nuclear medicine company. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan, media contact for Curium: firstname.lastname@example.org.