02/27/09: Salix Drug Nears FDA OK
Morrisville-based Salix Pharmaceuticals said it expects to submit wording for a "black box warning" to the U.S. Food and Drug Administration by mid-March to speed marketing approval of its METOZOLV Orally Disintegrating Tablets for treating gastric distress.
Salix got word last November from the FDA that there would be a three-month delay in a review of its New Drug Application for METOZOLV (metoclopramide hydrochloride). At that time the agency didn't ask for more data, but said it needed more time for its review of Salix's application.
An FDA action Thursday brought another delay in approval of the new product, however, by calling for all manufacturers of metoclopramide in the United States to provide the boxed warning, called a "risk evaluation and mitigation strategy," for their products.
"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," said Bill Forbes, PharmD, vice president, research and development and chief development officer.
"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."