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.

Related Content

Researchers receive grant worth millions to develop portable PET scanner
Why is the US still dependent on foreign medical isotope production?
Downed high-flux reactor could restart sooner than anticipated
Some nuc med departments are already feeling the strain of the isotope shortage
NorthStar opens facility to assist with development and distribution of vital radioisotopes
Lizard saliva could be key to spotting elusive pancreatic tumors

Around the web

Cardiovascular Business
Positron partners with Upbeat Cardiology Solutions to improve cardiac PET/CT access

Positron, a New York-based nuclear imaging company, will now provide Upbeat Cardiology Solutions with advanced PET/CT systems and services. 

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Design by Adaptive Theme
Trimed Popup
Trimed Popup