17 September 2010

Novartis withdraws application for EU approval of Rasival

The European Medicines Agency confirmed that Novartis withdrew its application for Rasival (aliskiren/valsartan) for the treatment of essential hypertension in patients whose blood pressure is adequately controlled through separate but concurrent dosing of the drug's two components.
In its letter, the drugmaker said its decision not to pursue approval of the drug was based on its inability to address requests from the agency's Committee for Medicinal Products for Human Use and provide additional data within the allowed timeframe.
Reference Articles
Novartis Europharm withdraws its marketing authorisation application for Rasival (aliskiren/valsartan) - (EMA)
EU drug panel: Novartis Europharm withdraws drug marketing application - (Morningstar)

**Published in "First Word"

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