Salix to provide REMS for Metozolv

The USA's Salix Pharmaceuticals has been asked to provide a risk  evaluation and mitigation strategy by the Food and Drug Administration  before it can progress the New Drug Application for Metozolv ODT  (metoclopramide HCl) orally-disintegrating tablets, 5mg and 10mg.

Bill Forbes, Salix'chief development officer, said: "we are pleased to  announce that the agency has completed its review of the application  and, with the exception of the REMS requirement, all substantive  questions and issues surrounding the Metozolv ODT application have been  resolved." He added that Salix intends to submit the REMS by mid-March.  All manufacturers of products containing metoclopramide will have to  provide a REMS.