FDA Approves Intravenous Rolapitant for CINV

October 26, 2017 – The FDA has approved intravenous (IV) rolapitant for use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting (CINV) in adults, according to Tesaro, the manufacturer of the agent. Delayed nausea and vomiting occurs between 25 and 120 hours after chemotherapy. The FDA previously approved oral rolapitant for this indication in September 2015. The IV approval was based on a bioequivalence trial that … (leggi tutto)