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Amitiza Approval History

  • FDA approved: Yes (First approved January 31st, 2006)
  • Brand name: Amitiza
  • Generic name: lubiprostone
  • Dosage form: Capsules
  • Company: Sucampo Pharmaceuticals, Inc.
  • Treatment for: Constipation, Chronic, Irritable Bowel Syndrome

Amitiza (lubiprostone) is a selective chloride channel activator for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women.

Development History and FDA Approval Process for Amitiza

Apr 23, 2013Approval FDA Approves Amitiza for Opioid-Induced Constipation
Sep 17, 2007FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
Jan 31, 2006Approval Amitiza - Sucampo Pharmaceuticals, Inc. - Treatment for Constipation
Apr  1, 2005Sucampo Submits New Drug Application for Lubiprostone, an Investigational Compound for the Treatment of Chronic Idiopathic Constipation

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