Solvay Pharmaceuticals Inc. Suspends Sales of LUVOX® in the United States after FDA Exclusivity Expiration
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Solvay Pharmaceuticals Inc. Suspends Sales of LUVOX® in the United States after FDA Exclusivity Expiration
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Solvay Pharmaceuticals Inc., Marietta, Georgia, has voluntarily requested the withdrawal of the U.S. Food & Drug Administration's original approval for LUVOX® (fluvoxamine maleate) Tablets, in the United States only. All other countries where fluvoxamine maleate is available for patients will remain entirely unaffected by this decision.
The turnover generated by LUVOX® in the United States has sharply declined since its U.S. FDA exclusivity expired, in June 2000. The bulk of Solvay's fluvoxamine maleate sales are now in Japan and the European Union. The interruption of LUVOX® shipments in the US does not affect the prospects of the Group's pharmaceutical sector for 2002.
Both the FDA and the company have no concerns over the safety or efficacy of LUVOX®.
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. administrative policy concerns. Prior to withdrawal of the application, Solvay Pharmaceuticals suspended further shipments of LUVOX® in the U.S. only.
SOLVAY PHARMACEUTICALS, Inc. (www.solvaypharmaceuticals-us.com) 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 some 31,400 people in 50 countries. In 2001 its consolidated sales amounted to EUR 8.7 billion generated by its four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com