Industry News

^{This page lists news from IFFGD Industry Council Members. No endorsement is intended or implied.}

What's in the news

Rifaximin

November 16, 2011 – Salix Pharmaceuticals announced that the FDA Gastrointestinal Drugs Advisory Committee supported the proposed design of a clinical trial to evaluate the safety, efficacy and durability of response with repeat treatment cycles of rifaximin for IBS with diarrhea. Find out more here.

Linaclotide

October 24, 2011 – The FDA has accepted for review the New Drug Application (NDA) for linaclotide to treat irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The review, which will determine whether or not the FDA approves the drug, is expected to take 10 months with a target date to occur in June 2012. Find out more here.

Solesta

September 6, 2011 – Oceana Therapeutics today announced the U.S. launch of Solesta, a significant new treatment option for patients with fecal (bowel) incontinence for whom conservative therapies have failed. Find out more here. 

InterStim Therapy

April 1, 2011 – Medtronic, Inc. today announced FDA approval of InterStim Therapy for the treatment of chronic bowel or fecal incontinence in patients who have failed or are not candidates for more conservative treatments. Find out more here.

Metozolv

September 8, 2009 – The FDA has granted marketing approval for the drug metoclopramide (Metozolv) 5mg and 10 mg orally disintegrating tablets. The drug is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults and the treatment of symptomatic documented GERD in adults who do not respond to conventional therapy. Therapy should not exceed 12 weeks in duration. Important safety information should be discussed with your doctor. Find out more here.

Kapidex/Dexilant

January 30, 2009 – The U.S. Food and Drug Administration (FDA) today approved KAPIDEX™ (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release™ (DDR) formulation designed to provide two separate releases of medication. Find out more here.

Kapidex changed its name to Dexilant in April 2010. 

Amitiza

April 29, 2008 – The U.S. Food and Drug Administration (FDA) today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome where constipation is the predominant bowel symptom (IBS-C) in adult women aged 18 and over. The efficacy of Amitiza in men was not conclusively demonstrated, said the FDA. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS with constipation available in the United States. Find out more here.   

July 12, 2007 – Amitiza became the first selective chloride channel activator approved by the FDA for the treatment of chronic idiopathic ("functional") constipation in adults.