Solvay withdraws Synordia EMEA submission due to time constraints

Belgium's Solvay Pharmaceuticals says that its subsidiary, Fournier Laboratories Ireland, has formally notified the European Medicines Agency (EMEA) of its decision to withdraw its application for a centralized marketing authorization for Synordia, the brand name proposed for its fixed-dose oral combination of fenofibrate and metformin. The agent is intended to be an adjunct to changes to diet and exercise to improve glycemic control and dyslipidemia in patients with type 2 diabetes, for use by those who require both fenofibrate and metformin and have already been stabilized on each drug. The withdrawal is due to the fact that Solvay cannot respond to the EMEA's request for additional information within the allowed timeframe and the firm stressed that the move does not prejudice the possibility of a new application at a later stage.