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# Tesaro Files NDA for Varubi IV Formulation
- URL: https://www.fdaweb.com/tesaro-files-nda-for-varubi-iv-formulation/
- Published: 2016-03-14T12:00:00.000Z
- Updated: 2026-09-15T02:43:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135060

> Tesaro has submitted an NDA for an intravenous formulation of Varubi (rolapitant), indicated for use in combination with other antiemetic agents in adults for preventing delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. The P/neurokinin-1 receptor antagonist was originally approved in a tablet formulation 9/1/2015\. The submission is supported by data from a clinical program that enrolled more than 400 subjects and included a bioequivalence study and several other supportive non-clinical and clinical studies, according to the company.