ST. LOUIS, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Curium, the world’s leading nuclear medicine company, announced today that it intends to submit updated labeling to the U.S. Food and Drug Administration (FDA) for its generic version of DaTscan™ (Ioflupane I 123 Injection) to include a new indication and updated safety information. The additional indication will be to assist in the evaluation of adult patients for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging with suspected dementia with Lewy bodies (DLB). Curium intends to match the labeling recently approved by the FDA for GE Healthcare’s DaTscan on November 3, 2022 as generic drugs are required to have the same labeling as the reference listed drug (DaTscan). Curium will update Ioflupane I 123 Injection important risk information to include the new safety information at the time of labeling implementation. Ioflupane I 123 Injection is a SPECT brain imaging agent used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes.

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Curium Announces New Indication for Ioflupane I 123 Injection in the U.S.