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news.Salix Pharmaceuticals, a specialty pharmaceutical company, has announced that Wilmington Pharmaceuticals has received a complete response letter from the FDA for its new drug application for Metozolv orally disintegrating tablets, 5mg and 10mg.
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Also, in a separate action, the FDA issued a class-wide requirement for all manufacturers of metoclopramide in the US to provide a risk evaluation and mitigation strategy (REMS) for their products. As a consequence of this action, the FDA indicated in complete response letter that a REMS for Metozolv orally disintegrating tablets (ODT) is required prior to approval of the new drug application.
Bill Forbes, chief development officer of Salix, said: “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 2009 and will work with the FDA to expedite the approval of Metozolv ODT.”