Prescription medicine

Telavancin Brand names: Vibativ

Telavancin (Vibativ) is a prescription medicine with an FDA approval on record since 2009. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the telavancin FDA label on DailyMed (effective December 19, 2025, Cumberland Pharmaceuticals Inc.); the NDA 22110 record on Drugs@FDA; every telavancin label on DailyMed.

Highlights of the record

FDA label of December 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL ADVERSE DEVELOPMENTAL OUTCOMES.

Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk [see Warnings and Precautions ( 5.1 , 8.4 )]. Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see Warnings and Precautions ( 5.3 )]. Embryofetal Toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose [see Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. […]

Used for

From the label: indications and usage
VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus.

Forms and strengths

15 mg/ml

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file: September 11, 2009 Vibativ, Apotex; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: January 1, 2027 Vibativ injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 118 through July 30, 2026

What is telavancin used for?

From the label: indications and usage
VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI) ( 1.1 ) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus. VIBATIV should be reserved for use when alternative treatments are not suitable. […]

FDA pharmacologic class: Lipoglycopeptide Antibacterial.

Source: FDA drug label (VIBATIV), NDA022110 (Apotex), as published by Cumberland Pharmaceuticals Inc., effective December 19, 2025 (SPL set 5359b759-db7c-4672-9e8a-59c93869bd91), via openFDA; the full label on DailyMed

What does the patient leaflet for telavancin say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about VIBATIV?
VIBATIV can cause serious side effects, including: Increased risk of death. VIBATIV was associated with an increased risk of death compared to vancomycin in people who already had kidney problems and were treated for bacterial pneumonia that you can get when you are in the hospital. New or worsening kidney problems. Your healthcare provider should do a blood test to check your kidneys before you start, while you receive, and after you stop receiving VIBATIV. VIBATIV may harm your unborn baby. If you are a woman who can become pregnant, your healthcare provider should do a pregnancy test before you start receiving VIBATIV. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Your healthcare provider will decide if VIBATIV is the right medicine for you. Women who can become pregnant should use effective birth control (contraception) while receiving VIBATIV and for 2 days after the last dose of VIBATIV. Talk to your healthcare provider if you have questions about birth control.

Is there a generic for telavancin (Vibativ)?

No generic telavancin is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Vibativ injection: the compound patent runs to January 1, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2009 earliest approval on file
2027 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the telavancin label say about other medicines?

The telavancin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Heparin	contraindications	CONTRAINDICATIONS Intravenous Unfractionated Heparin Sodium ( 4.1 , 5.5 , 7.1 ) Known hypersensitivity to VIBATIV
Vancomycin	warnings and precautions	VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin. ( 5.6 , 6.2 ) Infusion-related reactions:

Check telavancin against other medicines

What do FAERS reports show for telavancin?

The FDA Adverse Event Reporting System holds 118 reports that list telavancin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 27 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Off Label Use (a use or a product term, not a reaction)19
Renal Failure Acute (named in the label)15
Blood Creatinine Increased12
Nausea (named in the label)12
Chills9
Thrombocytopenia7
Diarrhoea (named in the label)6
Dyspnoea6

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other lipoglycopeptide antibacterials: the pharmacologic class, with prices and generics
Telavancin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other