Solvay Pharmaceuticals withdraws its marketing authorization application for SYNORDIA® in Europe
Solvay Pharmaceuticals announced today that its subsidiary, Fournier Laboratories Ireland Ltd, formally notified the European Medicines Agency (EMEA) of its decision to withdraw its application for a centralized marketing authorization for SYNORDIA® in Europe. SYNORDIA® is the brand name proposed for Solvay Pharmaceuticals fixed-dose oral combination product of fenofibrate and metformin.
SYNORDIA® is intended to be used as an adjunct to changes to diet and exercise to improve glycaemic control and dyslipidaemia in patients with type 2 diabetes. It is intended for use in patients who require both fenofibrate and metformin and have already been stabilized on each drug.
The application for marketing authorization for SYNORDIA® was submitted to the EMEA on 17 July 2006. The withdrawal of SYNORDIA® is due to the fact that Solvay Pharmaceuticals is not able to respond to the EMEA’s request for additional information within the allowed timeframe. Withdrawal of an application does not prejudice the possibility of Solvay Pharmaceuticals making a new application at a later stage.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets and men’s and women’s health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10000 people worldwide. For more information, visit solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30000 people in 50 countries. In 2005 its consolidated sales amounted to EUR 8.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext : SOLB.BE – Bloomberg: SOLB.BB – Reuters: SOLB.BR) is listed on the Euronext stock exchange in Brussels. Details are available at www.solvay.com