FDA clears cyclotron Ga-68 DOTATOC production process

By AuntMinnie.com staff writers

October 22, 2020 -- The University of Iowa in Iowa City has received clearance from the U.S. Food and Drug Administration (FDA) for a new process for producing via cyclotron the investigational radiopharmaceutical gallium-68 (Ga-68) DOTATOC for localizing neuroendocrine tumors.

Last year, the university received clearance to use a germanium-68/Ga-68 generator with a cassette-based synthesis model to manufacture Ga-68 DOTATOC. It then filed a supplement to seek clearance to produce the radiopharmaceutical on a cyclotron, it said.

The new process uses a zinc-68 solution to produce Ga-68 in the cyclotron; the solution is then transferred to a cassette-based synthesis module that purifies the Ga-68 and manufactures Ga-68 DOTATOC, the university said. The cyclotron process allows for more consistent production of the radiopharmaceutical.

The university has waived exclusivity for the Ga-68 DOTATOC new drug application and encourages other research entities to file Abbreviated New Drug Applications with the FDA based on it.


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