Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Expanded indications for gastric banding?: FDA's Gastroenterology and Urology Devices advisory panel will meet Dec. 3 to discuss whether the agency should approve expanded indications for Allergan's Lap-Band adjustable gastric banding system. The firm is seeking approval for use in slightly less obese patients, with a body mass index of at least 35 or a BMI of at least 30 if the individual has one or more obesity-related health condition. Currently, the device is labeled for adults with BMIs of 40 or more, or greater than 35 if the patient has a comorbidity. On Dec. 2, the panel will discuss Oceana Therapeutics' PMA for its Solesta fecal incontinence treatment for patients who have failed conservative therapy. The firm's 200-patient pivotal study for the hyaluronic acid-based product met its primary endpoints (1"The Gray Sheet" Dec. 14, 2009)