Sanofi-Aventis withdraws MAA for Aquilda; crucial new data expected before 2009
French drug major Sanofi-Aventis has withdrawn its European centralized marketing authorization application for Aquilda (satavaptan) after the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) asked for additional information on the therapeutic safety and efficacy of the agent, which is under review for euvolemic and hypervolemic dilutional hyponatraemia. In a letter to the agency, the company said it is currently developing this data but that the results will not be available before 2009.
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