NDA 215310, held by Takeda Pharms USA. Mobocertinib Succinate.
As of Nov 13, 2026, NDA 215310 (Exkivity), held by Takeda Pharms USA, was first approved by FDA on Sep 15, 2021, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ExkivityEQ 40MG BASE · capsule;oral | Mobocertinib Succinate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Mar 2, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Sep 15, 2021 | Original applicationNew molecular entity · Priority 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
