Quick answers
- What is Oritavancin used for?
- The FDA-approved label (Kimyrsa, Melinta Therapeutics, LLC, December 18, 2025) says: “KIMYRSA 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oritavancin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Oritavancin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oritavancin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oritavancin?
- 1 company lists prescription products of Oritavancin in the FDA NDC Directory, including Melinta Therapeutics, LLC.
What Oritavancin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KIMYRSA 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. …
— FDA label: Kimyrsa, Melinta Therapeutics, LLC, effective December 18, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Melinta Therapeutics, LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206334 ORBACTIV | Melinta Therap | August 6, 2014 | 7, latest January 14, 2022 2022: Labeling · 2021: Labeling · 2019: Labeling |
| NDA214155 KIMYRSA | Melinta Therap | March 12, 2021 | 2, latest April 24, 2025 2025: Labeling · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2532361, 2532366 |
|---|---|
| SPL set ID of the quoted label | 5e755c40-6e73-4572-b474-4d8a131693d1 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206334, NDA214155 |
| Active ingredients (FDA) | ORITAVANCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kimyrsa, Melinta Therapeutics, LLC, effective December 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →