NDA 208870, held by Jubilant. Technetium Tc-99m Exametazime Kit.
As of Nov 14, 2026, NDA 208870 (Drax Exametazime), held by Jubilant, was first approved by FDA on Aug 17, 2017, with 0 approved supplements and 0 published complete response letters.
Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 17, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Drax ExametazimeN/A · powder;intravenous | Technetium Tc-99m Exametazime Kit | Rx |
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
