Wednesday, July 8, 2026

Drug profile · INN

levofloxacin

levofloxacin (QUINSAIR) is a dna gyrase inhibitor. Associated with Teva Pharma GmbH. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved EMA: approved Antiinfectives for systemic use (J01) J01MA12
US status approved
Patents linked 1
Pipeline programs 9
News articles 0
Drug details — levofloxacin
US status
approved
Class
Antiinfectives for systemic use (J01)
Route
OPHTHALMIC
Patents
1
Programs
9
Data quality
0.89

Quick answer

levofloxacin (QUINSAIR) is a dna gyrase inhibitor. Associated with Teva Pharma GmbH. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN levofloxacin
Brand QUINSAIR
Mechanism DNA gyrase inhibitor
Target DNA gyrase
Therapeutic class Antiinfectives for systemic use (J01)
Route OPHTHALMIC
Formulation INJECTABLE
ATC code J01MA12

Mechanism of action

DNA gyrase inhibitor

Primary target: DNA gyrase

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. APHP220763 Phase 3 · PARItec · Catheter related bloodstream infections due to Staphylococcu
  2. APHP220814 Phase 3 · PARItec · Community-acquired pneumonia
  3. APHP241013 Phase 3 · PARItec · Young Adults and adults with R/R B-cell acute lymphoblastic
  4. NCT02735707 Phase 3 · Disc Medicine · Respiratory tract infection
  5. ALL3024 Phase 2 · Telethon Foundation · Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL)
  6. AB.OH.2025 Approved · George Institute for · Infectious diseases
  7. Levofloxacin Approved · Hospital Authority · Urinary Tract Infection
  8. P160929J Approved · PARItec · Community acquired pneumonia (CAP)

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. cinoxacin Bacterial DNA gyrase inhibitor
  3. ciprofloxacin Bacterial DNA gyrase inhibitor
  4. ciprofloxacin hydrochloride Bacterial DNA gyrase inhibitor
  5. colistimethate sodium Antiinfectives for systemic use (J01)
  6. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  1. US 7629458

    Preparation of levofloxacin and hemihydrate thereof

    Expires Mon Dec 03 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is levofloxacin?

levofloxacin (QUINSAIR) is a dna gyrase inhibitor. Associated with Teva Pharma GmbH. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for levofloxacin?

QUINSAIR is a marketed brand name for levofloxacin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of levofloxacin?

levofloxacin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.