FDA warns Salix on omitting risks and broadening indication for Metozolv
This article was originally published in Scrip
Executive Summary
The US FDA has sent Salix Pharmaceuticals a warning letter, stating that certain promotional materials – including a "Now Approved" journal launch ad - for Metozolv ODT are false and misleading because "they omit and minimise risk information, broaden the indication… and contain unsubstantiated comparative and other claims". Metozolv ODT, an orally disintegrating formulation of metoclopramide HCl, was approved last September to treat short-term refractory gastroesophageal reflux disease (GORD) and diabetic gastroparesis, and made available to pharmacies in November (scripnews.com, 14 September 2009).