Positron subsidiary nets FDA drug master file for Sr-82

| | Health Imaging | Molecular Imaging

Positron's subsidiary, Manhattan Isotope Technology (MIT), has received an acknowledgment letter and Drug Master File (DMF) number assignment from the FDA for its strontium-82 drug substance.

MIT of Lubbock, Texas, said it has has received acknowledgment from the FDA for its strontium-82 (Sr-82) drug substance submission. MIT is now permitted to submit letters of authorization (LOA) with companies supplying Sr-82/rubidium-82 (Rb-82) generators. The LOA requests MIT's DMF information be referenced in support of the holders aNDA/NDA applications. This acknowledgment is a requirement which enables the FDA to review information in the DMF with respect to these applications.

Rubidium-82 generators using the parent isotope Sr-82 can be used in myocardial perfusion imaging with PET.

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