Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Approves Johnson & Johnson’s Remicade for Pediatric Ulcerative Colitis

By Pharmaceutical Processing | September 26, 2011

Johnson & Johnson announced Friday that Remicade (infliximab) garnered FDA approval for use in children with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy.

 

The decision, which follows a positive recommendation from an advisory panel in July, was based on data from a late-stage trial involving 60 children ages 6 years to 17 years with moderately to severely active ulcerative colitis, all of which had failed to respond to or tolerate conventional treatment. Johnson & Johnson noted that data showed that Remicade induced a clinical response in 73 percent of patients at week 8 and demonstrated a safety profile that was “consistent with previous clinical trials conducted in an adult population.”

 

The therapy is already approved as a treatment for adults with ulcerative colitis, as well as several other conditions.

 

Related Articles Read More >

FDA logo
Ultra Supplement announces recall for undeclared tadalafil
analyzing medical sample
Expert answers to nitrosamine impurity questions
Cardinal Health
Cardinal Health announces $124M settlement of investors’ opioid suit
FDA logo
FDA warns four companies over selling honey tainted with prescription drugs

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards