Dalvance

Treats acute bacterial skin and skin structure infections (ABSSSI) caused by designated…. NDA 21883, held by Abbvie. Dalbavancin Hydrochloride.

As of Nov 14, 2026, NDA 21883 (Dalvance), held by Abbvie, was first approved by FDA on May 23, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: May 23, 2014
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DALVANCE is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial drugs, DALVANCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Jul 22, 2021	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 20, 2016	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
May 23, 2014	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
DalvanceEQ 500MG BASE/VIAL · powder;intravenous	Dalbavancin Hydrochloride	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Jan 13, 2025	Supplement 12Labeling · Standard review	Approved	Letter Label
Jul 22, 2021	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 24, 2018	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 20, 2016	Supplement 4Labeling · Priority review	Approved	None posted
Jan 20, 2016	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Dec 18, 2015	Supplement 2Labeling · Standard review	Approved	Letter
Nov 20, 2014	Supplement 1Manufacturing · Priority review	Approved	None posted
May 23, 2014	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 21883
Drugs@FDA: Overview at FDA
Company: AbbVie

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