Treats acute bacterial skin and skin structure infections caused or suspected. NDA 206334, held by Melinta Therap. Oritavancin Diphosphate.
As of Nov 13, 2026, NDA 206334 (Orbactiv), held by Melinta Therap, was first approved by FDA on Aug 6, 2014, with 7 approved supplements and 0 published complete response letters.
ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OrbactivEQ 400MG BASE/VIAL · powder;intravenous | Oritavancin Diphosphate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Jul 23, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Dec 11, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 4Labeling · Standard review | Approved | |
| Oct 17, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Jan 20, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Jul 14, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 6, 2014 | 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
