RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced that earlier today Wilmington Pharmaceuticals received a complete response letter from the U.S. 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 today, 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 this action, the FDA indicated in today’s complete response letter that a REMS for METOZOLV ODT is required prior to approval of the NDA. Commenting on today’s action, Bill Forbes, PharmD, 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 labeling 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.”
