NDA 208547, held by Novartis. Gallium Dotatate Ga-68.
As of Nov 15, 2026, NDA 208547 (Netspot), held by Novartis, was first approved by FDA on Jun 1, 2016, with 10 approved supplements and 0 published complete response letters.
NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2016 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Netspot2.1-5.5mCi/ML · powder;intravenous | Gallium Dotatate Ga-68 | RxReference drug |
| Oct 26, 2023 | Supplement 27Labeling · Standard review | Approved | |
| Dec 22, 2021 | Supplement 24Labeling · Standard review | Approved | |
| Jun 22, 2021 | Supplement 22Labeling · Standard review | Approved | |
| Jun 22, 2021 | Supplement 20Labeling · Standard review | Approved | |
| Sep 27, 2018 | Supplement 12Manufacturing | Approved | None posted |
| Aug 9, 2018 | Supplement 13Manufacturing | Approved | None posted |
| Apr 12, 2018 | Supplement 11Labeling · Standard review | Approved | |
| Jan 20, 2017 | Supplement 4Manufacturing · Standard review | Approved | |
| Oct 31, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 2, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Jun 1, 2016 | 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
