Vibativ

NDA 22110, held by Apotex. Telavancin Hydrochloride.

As of Nov 13, 2026, NDA 22110 (Vibativ), held by Apotex, was first approved by FDA on Sep 11, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 11, 2009
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved 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) 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs VIBATIV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


May 6, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 11, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


VibativEQ 250MG BASE/VIAL · powder;intravenous	Telavancin Hydrochloride	DiscontinuedReference drug
VibativEQ 750MG BASE/VIAL · powder;intravenous	Telavancin Hydrochloride	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Jul 7, 2020	Supplement 16Labeling · Standard review	Approved	Letter Label
Feb 20, 2020	Supplement 15Labeling · Standard review	Approved	Letter Label
May 24, 2017	Supplement 14REMS	Approved	Letter
May 6, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 23, 2016	Supplement 13REMS	Approved	Letter
Dec 3, 2014	Supplement 11Labeling · Standard review	Approved	Label Letter
Nov 12, 2014	Supplement 10REMS	Approved	Letter
Mar 13, 2014	Supplement 9Manufacturing · Standard review	Approved	Label
Feb 7, 2014	Supplement 7Labeling · Standard review	Approved	Label
Dec 12, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 21, 2013	Supplement 3REMS	Approved	Letter Label
May 31, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 1, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 27, 2011	Supplement 2REMS	Approved	Letter
Sep 11, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22110
Drugs@FDA: Overview at FDA
Company: Apotex

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