Synthes to fight off-label promotion charges
This article was originally published in Clinica
Executive Summary
Swiss orthopaedics firm Synthes is to defend itself against a charge of allegedly promoting the use of its Norian XR calcium phosphate bone void filler for unapproved indications. The firm received an indictment from the US attorney for the Eastern district of Pennsylvania but claims that “marketing practices in connection with Norian XR were proper”. Norian XR was granted FDA approval in 2002 for the treatment of bone voids or defects in the skeletal system. According to Synthes, the technology was marketed from 2002 to 2004, when approximately 200 units were sold and revenue of $400,000 was generated.