FDA Grants Marketing Approval For Salix’s METOZOLV ODT

FDA has granted marketing approval for Salix Pharmaceuticals’ (Salix) METOZOLV ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets.

METOZOLV ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.

Bill Forbes, senior vice president of research and development and chief development officer at Salix, said: “The addition of METOZOLV ODT to Salix’s expanding GI-specialty product portfolio provides physicians and patients an innovative treatment choice that may offer improved convenience over traditional metoclopramide therapy.

“METOZOLV ODT – the first commercially available orally disintegrating form of metoclopramide for the relief of diabetic gastroparesis and symptomatic gastroesophageal reflux to market. We anticipate METOZOLV ODT should be available for physicians and patients during November 2009.”