MARIETTA, Ga. - Solvay Pharmaceuticals, Inc. has requested the withdrawal of New Drug Application (NDA) 20-243 from the U.S. Food and Drug Administration (FDA) for LUVOX® (fluvoxamine maleate) Tablets from the U.S. market.
Neither the FDA nor the company has concerns over the safety or efficacy of LUVOX®. Solvay Pharmaceuticals plans to refile its NDA application for LUVOX®, and the company anticipates the product will return to the market. 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, but FDA interprets its policies as having to keep the product off the market until the agency's refiling review process is complete.
This withdrawal has no relation to the immediate release forms of fluvoxamine manufactured and sold in several countries around the world, and is based solely on U.S. FDA administrative policy concerns. Before submitting the request, Solvay Pharmaceuticals suspended further shipments of LUVOX® in the U.S. only.
LUVOX® was the leading selective serotonin reuptake inhibitor (SSRI) prescribed in the U.S. by psychiatrists for the treatment of obsessive compulsive disorder (OCD), until December 2000 when several generic fluvoxamine products entered the market. FDA approval and continued market presence of generic fluvoxamine reaffirms the safety, efficacy and medical importance of LUVOX® Tablets in treating mental health disorders.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay chemical and pharmaceutical group, headquartered in Brussels, Belgium.
Solvay is an international chemical and pharmaceutical group with headquarters in Brussels. It employs about 31,400 people in 50 countries. In 2001 its consolidated sales amounted to EUR 8.7 billion generated by its four sectors of activity: Pharmaceuticals, Chemicals, Plastics and Processing. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.
Contact:
Karen Carlisle 770-578-5581 or
Gabrielle Andres 770-578-5637
Solvay Pharmaceuticals, Inc.
