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Linzess Approval History

FDA Approved: Yes (First approved August 30, 2012)
Brand name: Linzess
Generic name: linaclotide
Dosage form: Capsules
Company: Allergan plc
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).

Development History and FDA Approval Process for Linzess

DateArticle
Jan 26, 2017Approval U.S. FDA Approves 72 mcg Dose of Linzess (linaclotide) for Adults with Chronic Idiopathic Constipation
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

Further information

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