Linzess Approval History

  • FDA approved: Yes (First approved August 30th, 2012)
  • Brand name: Linzess
  • Generic name: linaclotide
  • Company: Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc.
  • Treatment for: Irritable Bowel Syndrome, Constipation, Chronic

Linzess (linaclotide) is a guanylate cyclase-C agonist indicated in adults for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

FDA Approval History for Linzess

DateArticle
Aug 30, 2012Approval FDA Approves Linzess to Treat Certain Cases of Irritable Bowel Syndrome and Constipation
Feb  8, 2012Ironwood Announces FDA Advisory Committee Meeting Will Not Be Scheduled in Connection with New Drug Application for Linaclotide
Oct 24, 2011Ironwood and Forest Announce Linaclotide New Drug Application for the Treatment of Irritable Bowel Syndrome with Constipation and Chronic Constipation Accepted for FDA Review
Aug  9, 2011Ironwood and Forest Announce Submission of New Drug Application for Linaclotide for the Treatment of Irritable Bowel Syndrome with Constipation and Chronic Constipation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)