New intravenous formulation of Varubi (rolapitant) for nausea filed with FDA- Tesaro
Tesaro has submitted a New Drug Application (NDA) for an intravenous formulation of Varubi (rolapitant), for nausea, to the FDA. The NDA for IV rolapitant is supported by data from a clinical programme that enrolled more than 400 subjects and included a bioequivalence study and several other supportive non-clinical and clinical studies. Tesaro anticipates a standard 12-month review timeline for the iv rolapitant NDA.
Comment: The FDA approved Varubi on 1 September 2015 for use in combination with other antiemetic agents in adults, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. It is currently marketed as a tablet.
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