Salix metoclopramide drug moves closer to FDA approval
The Food and Drug Administration (FDA) has accepted the complete response from Salix Pharmaceuticals for its orally disintegrating tablet (ORT) form of metoclopramide called Metozolv, and says it has granted a Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products, for September 11, 2009. Salix is seeking approval for its drug in the treatment of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal refulx (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (delayed emptying of the stomach).