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

Clarification

This article was originally published in The Gray Sheet

Executive Summary

"The Gray Sheet" incorrectly characterized Johnson & Johnson's Ionsys transdermal, on-demand analgesic drug dosing system as a pump. The device uses iontophoresis to deliver fentanyl (1"The Gray Sheet" May 29, 2006, In Brief)...

You may also be interested in...



J&J Ionsys fentanyl pump for post-surgical pain to launch in 2007

Johnson & Johnson subsidiary Alza will launch in 2007 its Ionsys needle-free, patient-activated iontophoresis transdermal fentanyl drug delivery system for post-operative pain, the firm says. FDA approved the system May 22 for short-term management of post-operative pain in adults requiring opioid analgesia during hospitalization. Ionsys' E-Trans delivery technology uses low-intensity electrical current to move a 40 mcg dose of fentanyl from a reservoir into the skin over a 10-minute period. Alza also markets the controlled-release fentanyl patch Duragesic. The road to approval for Ionsys has been relatively long. A September 2003 NDA filing was deemed "approvable" in July 2004. The company resubmitted the application in November 2005...

US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates

US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.

UsernamePublicRestriction

Register

MT023612

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