Prevents delayed nausea and vomiting associated with initial and repeat courses of…. NDA 206500, held by Tersera. Rolapitant Hydrochloride.
As of Nov 13, 2026, NDA 206500 (Varubi), held by Tersera, was first approved by FDA on Sep 1, 2015, with 4 approved supplements and 0 published complete response letters.
VARUBI is indicated 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 1, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VarubiEQ 90MG BASE · tablet;oral | Rolapitant Hydrochloride | RxReference drug |
| Aug 19, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Apr 13, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Apr 22, 2016 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 4, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 1, 2015 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
