CLINICAL & PIPELINE·Drug Approval
TERSERA's VARUBI (ROLAPITANT HYDROCHLORIDE) IV Emulsion: FDA Approval and Subsequent Discontinuation Impact
TERSERA's VARUBI (ROLAPITANT HYDROCHLORIDE) intravenous emulsion received FDA approval as a new dosage form (NDA208399) on October 25, 2017. Despite initial regulatory success, the product's marketing status is now discontinued. This event signals critical considerations for regulatory affairs, procurement, and business development teams regarding product lifecycle management and market dynamics for antiemetic therapies.
90-Day Activity