Status of LUVOX® (fluvoxamine maleate) Tablets Solvay Pharmaceuticals, Inc. withdrew the new drug application (NDA) for LUVOX® (fluvoxamine maleate) Tablets in May 2002. Upon submission of the NDA withdrawal request, Solvay Pharmaceuticals suspended further shipments of LUVOX® on May 10, 2002 in the U.S. only. Neither the FDA nor the company has concerns over the safety or efficacy of LUVOX®.  The withdrawal relates solely to the interpretation of data supporting the chemistry, manufacturing and controls (CMC) section of the original NDA in the United States.  Solvay Pharmaceuticals has supplemental data that fully support the CMC issues. However, FDA interprets its policies as having to keep the product off the market until the agency’s refiling review process is complete.  FDA review and approval of the chemistry, manufacturing and controls (CMC) section of the NDA is a standard practice in assuring the continued supply of safe and effective drugs to the U.S. population. Solvay Pharmaceuticals refiled its NDA application for LUVOX® Tablets in June 2002 and anticipates returning the LUVOX® product to the market by the end of 2004.