FDA approves generic version of brain imaging agent in US

The FDA has approved the generic version of DaTscan (Ioflupane I 123), manufactured and commercialised by Curium. This is a single-photon emission computed tomography (SPECT) brain imaging agent used to assist in the evaluation of adult patients with suspected Parkinsonian Syndromes.

Ioflupane I 123 Injection may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy).

“The number of patients being diagnosed with Parkinsonian Syndromes is, unfortunately, growing. Approximately 1% of the population over the age of 65 are affected and that population is increasing. The addition of Curium’s generic Ioflupane I 123 Injection to the market will offer appropriate patients an opportunity to be scanned Monday through Thursday early in the morning,” said Michael Patterson, Curium’s North American CEO. “Providing hospitals and imaging centers the opportunity to scan patients on a day or at a time not currently available offers flexibility when scheduling this important study.”

“Ioflupane I 123 Injection is an important tool many neurologists and movement disorder specialists use when diagnosing adult patients with suspected Parkinsonian Syndromes,” said Ed Porter, North American Vice President of Medical and Compliance. “Over the past two years Curium has introduced several new products, both branded and generic, which help physicians diagnose patients. We are thrilled to add Ioflupane I 123 Injection to that growing list of medicines to help patients move life forward.”

Lina Adams