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DaTscan Approval History

  • FDA approved: Yes (First approved January 14th, 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 History and FDA Approval Process 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

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