Tesaro gets CRL for IV rolapitant

Tesaro Inc. (NASDAQ:TSRO) received a complete response letter from FDA for biotech's IV formulation of rolapitant (SCH 619734) to prevent chemotherapy-induced nausea and vomiting (CINV).

At FDA's request during the NDA review, Tesaro provided in vitro data to demonstrate comparability between drug product made by the two manufacturers included in the submission. The company had secured the second manufacturer after identifying “potential deficiencies” at its originally contracted supplier...