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Trulance FDA Approval History

FDA Approved: Yes (First approved January 19, 2017)
Brand name: Trulance
Generic name: plecanatide
Dosage form: Tablets
Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation, Chronic, Irritable Bowel Syndrome

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

Development Timeline for Trulance

DateArticle
Jan 25, 2018Approval Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults
Jan 19, 2017Approval FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation
Dec  9, 2016Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
Jul 15, 2016Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program
Apr 19, 2016Synergy Pharmaceuticals Announces Acceptance of NDA for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation
Jan 29, 2016Synergy Pharmaceuticals Files NDA for Plecanatide in Chronic Idiopathic Constipation

Further information

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