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Merck & Co Inc's New Drug Application For An Investigational Intravenous (IV) Formulation Of Noxafil (Posaconazole) Receives FDA Priority Review


Monday, 18 Nov 2013 08:30am EST 

Merck & Co Inc announced that its New Drug Application for an investigational intravenous (IV) solution formulation of the Company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration (FDA). Priority review designation is assigned to applications for drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The company also has filed a marketing authorization application for NOXAFIL IV solution with the European Medicines Agency (EMA) and plans to seek regulatory approval for the IV formulation in other countries around the world. NOXAFIL is contraindicated in persons with known hypersensitivity to posaconazole, any component of NOXAFIL, or other azole antifungal agents. NOXAFIL (posaconazole) is contraindicated with sirolimus. Concomitant administration of NOXAFIL with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity. NOXAFIL is contraindicated with CYP3A4 substrates that prolong the QT interval. Concomitant administration of NOXAFIL with the CYP3A4 substrates pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to QTc prolongation and rare occurrences of torsades de pointes.