Industry News

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

What's in the news

Rifaximin

June 08, 2010 – Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21–361 for XIFAXAN^® (rifaximin) 550 mg tablets to the FDA for the proposed indication of treatment of non–constipation irritable bowel syndrome (Non–C IBS) and IBS–related bloating. Find out more here.

Solesta

April 12, 2010 – Oceana Therapeutics and Q-Med AB filed a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for Solesta® for the treatment of bowel incontinence. Solesta, which has been under development as a minimally invasive treatment for patients who have failed conservative therapy, is an injectable gel administered in an outpatient setting without the need for anesthesia. Find out more here.

Linaclotide

November 2009 – Linaclotide is a promising, first-in-class drug for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. It is now in Phase 3 clinical development. At therapeutic doses, linaclotide acts locally in the gut. Exposure in the body outside the gut has not been detected. 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.