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DaTscan FDA Approval History

FDA Approved: Yes (First approved January 14, 2011)
Brand name: DaTscan
Generic name: ioflupane I 123
Dosage form: Injection
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

DaTscan (ioflupane I 123 injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

Development timeline for DaTscan

Jan 18, 2011Approval FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes
Jun  2, 2009GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review

Further information

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