• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Canasa (mesalamine)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Canasa (mesalamine)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Canasa (mesalamine) is a rectal suppository that has been approved by the FDA for the treatment of active ulcerative proctitis. Ulcerative proctitis is a less severe form of ulcerative colitis - a disease that causes inflammation and ulcers in the top layers of the lining of the large intestine. Ulcerative proctitis differs from ulcerative colitis in terms of where the inflammation occurs. In ulcerative proctitis, inflammation is only present in the rectum, and the upper limit of inflammation is visible via sigmoidoscopy. In ulcerative colitis, inflammation usually occurs in the rectum and lower part of the colon, but it may affect the entire colon.

    In August 1999, the FDA requested that Axcan sell Canasa in the United States under a temporary, emergency measure due to the lack of any other source of supply. Subsequently, Axcan performed preclinical and clinical studies and filed an NDA on April 28, 2000. In conjunction with the approval, Axcan will perform a clinical study in children ages 12-18 years with active or quiescent (inactive) disease, since this condition may also be diagnosed at a young age.

    Side Effects

    Side effects that may occur with the use of drugs containing mesalamine include (but are not limited to) the following:


    • Allergic reaction
    • Nausea or vomiting
    • Abdominal cramping
    • Headache
    • Dizziness
    • Chills

    Mechanism of Action

    The manner in which mesalamine provides a therapeutic effect for ulcerative proctitis is currently unknown.

    Additional Information

    For additional information on Canasa, please visit Axcan's web site.

    Approval Date: 2001-01-01
    Company Name: Axcan
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • TechInnovation-360x240.png

      Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

    • AskTheExperts-360x240.png

      Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing