Trials & Filings

FDA Accepts CINV NDA

Helsinn, Eisai file for netupitant, palonosetron combo

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has accepted for review the NDA from Helsinn Group and Eisai Inc. for the investigational oral fixed-dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg (NEPA) for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly and moderately emetogenic chemotherapy.   The acceptance indicates that the FDA has found the submission to be sufficiently complete to review. Helsinn’s NDA is supported by data from pivotal studies...

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