FDA approves Siemens subsidiary's PET tracer
This article was originally published in Clinica
Executive Summary
PETNet Solutions, a subsidiary of imaging giant Siemens Healthcare, has received US approval for its PET tracer, Fludeoxyglucose (FDG) 18F Injection. Siemens Healthcare's Mark Palacio told Clinica that PETNet (Knoxville, Tennessee) is the first company to achieve approval of an abbreviated new drug application (ANDA) for FDG. 18F FDG is used to assess cancer patients for abnormal glucose metabolism, to assist in the evaluation of known or suspected abnormalities. It is also used in cardiology and neurology. The firm expects to see "significant benefits" in patient safety owing to "the tightly controlled manufacturing processes that are commensurate with an FDA-approved pharmaceutical". In fiscal year 2010, Siemens Healthcare posted revenue of €12.4bn and profit of around €750m.
You may also be interested in...
ITF Has A Fight On Its Hands In Duchenne
The group’s new muscular dystrophy pill seems unlikely to cut into Sarepta’s sales.
AbbVie Needs To Freshen Up
With half of its 2023 sales coming from aging blockbusters like Humira and Botox, AbbVie needs new blood.
AstraZeneca Pays $2bn To Keep Up With The Joneses
Bristol Myers Squibb and Lilly have recently done billion-dollar radiopharmaceuticals deals, and now the UK group wants a piece of the market. But can it make its Fusion fusion work?