Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: mesalamine; 5-aminosalicylic acid
Trade Name: Lialda
Date Designated: 02/27/2008
Orphan Designation: Treatment of ulcerative colitis in pediatric patients (revised indication 10/21/2010).
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: mesalamine; 5-aminosalicylic acid
Trade Name: Lialda
Marketing Approval Date: 06/26/2020
Approved Labeled Indication: Lialda (mesalamine) is indicated for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-