Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



Alere aided by professional diagnostics sales in fourth quarter

Alere’s professional diagnostics business helped the firm record overall revenue growth in the fourth quarter of 2010, offsetting a fall in influenza-based sales in North America.

Integra and Stout to work on expandable interbody device

Integra LifeSciences has gained exclusive worldwide rights from Stout Medical to develop and commercialise an expandable interbody fusion device.

Gen-Probe eyes portfolio expansion to help boost molecular diagnostics credentials

Gen-Probe recently launched its Panther automated molecular diagnostics system in Europe with the aim of bringing another dimension to its product portfolio. Joseph Harvey met the firm’s CEO, Carl Hull, at the launch of the product in Frankfurt to find how high the firm has set its sights in the molecular diagnostics sector and how it is going to achieve its goals

Topics

UsernamePublicRestriction

Register

MT042896

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel