FDA rejects Tesaro’s IV version of rolapitant, citing manufacturing issues
Tesaro’s plans for building up sales of Varubi — or rolapitant — through a new intravenous formulation of the drug will have to wait. The FDA shot down the biotech’s marketing application, which the biotech says is solely during to some outstanding manufacturing issues.
The pill version of the drug — used to treat chemo induced nausea and vomiting — was OK’d back in 2015, triggering a blockbuster projection from the company. Analysts, though, have been less than impressed with the rollout, with Leerink pulling back its forecast on sales.
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