Salix Pharmaceuticals, Ltd announced that Wilmington Pharmaceuticals received a complete response letter from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, 5 mg and 10 mg.
Also, in a separate action, the FDA issued a class-wide requirement for all manufacturers of metoclopramide in the United States to provide a risk evaluation and mitigation strategy (REMS) for their products. As a consequence of the action, FDA indicated in complete response letter that a REMS for Metozolv ODT is required prior to approval of the NDA.
Commenting on the action, Bill Forbes, vice president, Research and Development, chief development officer, Salix, stated, "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. In regard to the metoclopramide class-wide requirement for a REMS, the issue involves an adverse event of metoclopramide known as tardive dyskinesia, that is widely-known among healthcare professionals and is well-documented in the literature and current labelling of metoclopramide products. The decision of the FDA to elevate the warnings surrounding tardive dyskinesia to a boxed warning on the package insert requires the issuance of a medication guide that will be distributed to patients and healthcare professionals to better educate as to the proper use of metoclopramide. We intend to submit this newly-required item by mid March and will work with the FDA to expedite the approval of Metozolv ODT."
Salix Pharma develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.