For an abnormal mammogram or a palpable breast mass. Sold as Cardiolite, Miraluma. Every FDA application for this active ingredient: 1 branded and 4 generic.
As of Nov 15, 2026, FDA lists 5 applications for Technetium Tc-99m Sestamibi Kit (sold as Cardiolite, Miraluma), first approved Dec 21, 1990, with 5 new uses approved and 0 published complete response letters.
| Dec 21, 1990 | Cardiolite, MiralumaNDA 19785 ยท New molecular entity | Shine | 17 | Marketed |
| Sep 22, 2008 | Technetium Tc 99m SestamibiANDA 78098 | Curium | 2 | Marketed |
| Apr 28, 2009 | Technetium Tc 99m SestamibiANDA 78809 | Cardinal Health 414 | 1 | Marketed |
| Apr 29, 2009 | Technetium Tc 99m SestamibiANDA 78806 | Jubilant Draximage | 1 | Marketed |
| Jul 10, 2009 | Technetium Tc 99m SestamibiANDA 79157 | Sun Pharm Inds Inc | 1 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sun Pharm Inds Inc