Treats acute bacterial skin and skin structure infections caused or suspected. Sold as Orbactiv, Kimyrsa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Oritavancin Diphosphate (sold as Orbactiv, Kimyrsa), first approved Aug 6, 2014, with 0 new uses approved and 0 published complete response letters.
| Kimyrsa | Part B | $7.1M | -17% | 933 |
| Orbactiv | Part B | $2.2M | +10% | 313 |
| Kimyrsa | Part D | $437K | -33% | 51 |
| Orbactiv | Part D | $148K | -47% | 28 |
| Aug 6, 2014 | OrbactivNDA 206334 · New molecular entity | Melinta Therap | 7 | Marketed |
| Mar 12, 2021 | KimyrsaNDA 214155 · New formulation or manufacturer | Melinta Therap | 2 | Marketed |
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
