The European Union has accepted the Medicines Company's marketing authorization application (MAA) for Cleviprex for the reduction of blood pressure when rapid and predictable control is desired.
The Parsippany, N.J.-based company said its MAA for Cleviprex (clevidipine butyrate injectable emulsion) was submitted via the decentralized procedure, with the U.K. acting as the Reference Member State. Concerned member states participating in the review are Austria, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Spain and Sweden.
Cleviprex, an IV antihypertensive, represents advancement over currently available therapies, providing control of blood pressure in the critical-care setting, the company said. Backed by data in the emergency department, operating room and intensive care unit, Cleviprex was launched in the U.S. in 2008, offering physicians a new therapeutic option for the management of elevated blood pressure.
Medicines said it hopes to make Cleviprex available in the European Union in 2010.