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Helsinn Group and EISAI announce FDA acceptance of New Drug application for investigational compound netupitant 300 mg + palonestron 0.50 mg (NEPA)
Lugano, Switzerland and Woodcliff Lake, NJ, USA , December 9, 201 3 – Helsinn Group and Eisai Inc. today announced that the U .S. Food and Drug Administration (FDA) accepted for review the submission of the New Drug Application (NDA) for the investigation al oral fixed- dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg (N E PA) for prevention o f acute and delayed ch emotherapy – induced nausea and vomiting (CINV) following both highly and moderately emetogenic chemotherapy.