Levofloxacin
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Quinsair | — | 2015-03-25 | europa.eu ↗ |
| Label expansions (12) | US (FDA) | LEVAQUIN | — | 1998-12-17 – 2012-04-27 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | — | 2009-10-28 | “it submitted an application in Japan on October 28 to manufacture and market an injectable preparation of Levofloxacin Hydrate” daiichisankyo.com ↗ |
| Approved | US (FDA) | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | — | 1996-12-20 | fda.gov ↗ |
Trials 191 · started per year
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2018-06-01 | Lannett Company, Inc. | Regulatory Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch Anticipated investorroom.com ↗
"Our ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved three weeks ahead of the Target Action Date," said Tim Crew, chief executive officer of Lannett. |
| 2018-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Pharmaceutical Receives Approvals for Eight Molecules in 19 Presentations of Generic Drugs upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approvals by the Ministry of Health, Labour and Welfare for eight molecules in 19 presentations of generic drugs. |
| 2015-09-24 | Daiichi Sankyo | Regulatory Daiichi Sankyo Obtains Approval in Japan for Supplementary Indication of New Quinolone Antibacterial Injection, “Cravit® Intravenous Drip Infusion” daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has obtained approval for partial changes concerning a supplementary indication of their new quinolone antibacterial injections, Cravit® Intravenous Drip Infusion Bag 500mg/100mL and Cravit® Intravenous Drip Infusion 500mg/20mL (generic name: Levofloxacin Hydrate) to treat bacterial infections of urology, surgery, and gynecology. |
| 2015-08-24 | Daiichi Sankyo | Regulatory Daiichi Sankyo and Daiichi Sankyo Espha Obtain Approval in Japan for Supplementary Indication of “Cravit® Tablets, Granules” and “Levofloxacin Tablets, Granules DSEP” daiichisankyo.com ↗
Daiichi Sankyo and Daiichi Sankyo Espha Obtain Approval in Japan for Supplementary Indication of “Cravit® Tablets, Granules” and “Levofloxacin Tablets, Granules DSEP” |
| 2014-10-01 | Daiichi Sankyo | Regulatory Daiichi Sankyo and Daiichi Sankyo Espha Submit Supplemental New Drug Application in Japan for “Cravit® Tablets, Granules” and “Levofloxacin Tablets, Granules DSEP” daiichisankyo.com ↗
Daiichi Sankyo Company Limited (hereafter, Daiichi Sankyo) today announced that it and its domestic generic subsidiary, Daiichi Sankyo Espha Co., Ltd. (hereafter Daiichi Sankyo Espha), have submitted a supplemental New Drug Application (sNDA) in Japan for the synthetic broad-spectrum oral antibacterial agent Cravit® Tablets 250mg and 500mg, Granules 10% (generic name: Levofloxacin hemihydrate) and Levofloxacin Tablets 250mg DSEP and 500mg DSEP, Granules 10% DSEP*1 for the treatment of pulmonary and other tuberculosis disorders. |
| 2014-09-01 | Daiichi Sankyo | Regulatory Daiichi Sankyo Espha Receives Manufacturing and Marketing License in Japan for “Levofloxacin Tablets 250mg/500mg” and “Granules 10% DSEP” daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that its domestic generic drug subsidiary, Daiichi Sankyo Espha Co., Ltd. (hereafter Daiichi Sankyo Espha), obtained a manufacturing and marketing license in Japan on August 15, 2014 for Levofloxacin Tablets 250mg DSEP, 500mg DSEP and Granules 10% DSEP (hereafter Levofloxacin). |
| 2011-06-21 | Wockhardt | Regulatory WOCKHARDT LAUNCHES THREE NEW / PRODUCTS IN THREE WEEKS, IN THE UNITED STATES wockhardt.com ↗ |
| 2010-10-27 | Daiichi Sankyo | Regulatory Daiichi Sankyo receives approval in Japan to manufacture and market Cravit(R) intravenous injections daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has received approval in Japan to manufacture and market new formulations of Cravit® (generic name: levofloxacin hydrate). |
| 2009-10-29 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Application for Approval of Levofloxacin Hydrate Injection in Japan daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (TSE: 4568), announced today that it submitted an application in Japan on October 28 to manufacture and market an injectable preparation of Levofloxacin Hydrate that incorporates the company's new quinolone anti-bacterial agent. |
| 2009-04-22 | Daiichi Sankyo | Regulatory Daiichi Sankyo Obtains Manufacturing and Marketing Approval for new Cravit® Formulations daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (TSE: 4568), today obtained manufacturing and marketing approval in Japan for new formulations of Cravit® (generic name: Levofloxacin Hydrate), a broad-spectrum oral anti-bacterial agent. |
| 2005-02-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Levofloxacin Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDAs for Levofloxacin Injection, 5 mg/mL in 250 mg/bag and 500 mg/bag (5% dextrose bags) and Levofloxacin Injection, 25 mg/mL in 20 mL and 30 mL vials. |
| 2005-01-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval Of Levofloxacin Tablets, 750 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Levofloxacin Tablets, 750 mg. |
| 2004-04-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Levofloxacin Tablets, 250 Mg, 500 Mg, And 750 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Levofloxacin Tablets, 250 mg, 500 mg and 750 mg. |
All press releases naming this drug 24 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 340 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Levofloxacin | “Participants with positive results for infection received a standard 7-day triple therapy (esomeprazole 40 mg once daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg...” PMID 16961802 ↗ Oct 2006327“Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin,...” NCT07405697 ↗ “anti-bacterial tuberculosis drugs (pyrazinamide [PZA], ethambutol [EB, EMB], streptomycin [SM], kanamycin [KM, KAN], enviomycin [EVM], ethionamide [TH], cycloserine [CS],...” NCT02365623 ↗ “Group 2 will receive azithromycin 500 mg once daily (od) (Truxa®, Laboratorios Monte Verde SA, Argentina), levofloxacin 500 mg od (Laboratorios Asofarma de México SA de CV,...” NCT02726269 ↗ “Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through...” NCT00596167 ↗ “empiric initiation of the enhanced spectrum antimicrobial therapy regimen (rifampin, isoniazid, linezolid, and levofloxacin) for 14 days plus standard care which includes...” NCT07332325 ↗ “patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals)...” NCT06050824 ↗ “This study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected...” NCT07585461 ↗ “Experimental arms are seven oral regimens with a five-drug combination of the following: bedaquiline, linezolid, a fluoroquinolone (moxifloxacin or levofloxacin), cycloserine,...” NCT05081401 ↗ “Eligible patients will be treated with (esomeprazole 40mg bid +amoxicillin 1gm bid) for 5 days, followed by (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole...” NCT00885417 ↗ “Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid,...” NCT03565484 ↗ |
| Known as | Aeroquin | “MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery.” NCT01180634 ↗ |
| Known as | Cravit | “Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and” NCT01575899 ↗ |
| Known as | Cravit 0.5% | “patients with senile cataracts who were undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1 ml/0.5 mg; Cravit® 0.5%; Santen Pharmaceutical...” PMID 41038947 ↗ Oct 2025 |
| Known as | Generic name: Levofloxacin | “Generic name: Levofloxacin” NCT01761201 ↗ |
| Known as | HR355 | “Levofloxacin (HR355) and Rifampicin Therapy” NCT00906048 ↗ |
| Known as | LEV | “The purpose of this study was to compare the efficacy and safety of TGC with levofloxacin (LEV) in adult hospitalised patients with community-acquired pneumonia (CAP) in a...” PMID 19036672 ↗ Oct 2008 |
| Known as | Levaquin | “Groups 4, 5 and 6 received the same treatment with the corresponding oral dose of ofloxacin 400 mg (Floxin), ciprofloxacin 400 mg (Cipro) and levofloxacin 250 mg (Levaquin).” PMID 18211932 ↗ Jan 20083“The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole” NCT03303677 ↗ “Intravenous Levaquin initially, then oral dosing.” NCT03768869 ↗ |
| Known as | Levaquin=Levofloxacin | “Levaquin (levofloxacin)” NCT00596167 ↗1“Levaquin=Levofloxacin” NCT01074554 ↗ |
| Known as | LEVO | “In this open-labeled, randomized clinical trial, the Investigator will assess the safety and pharmacokinetics (PK) of model-optimized doses of rifampicin (RIF) with or without...” NCT02958709 ↗ |
| Known as | Levofloxacin hydrate | “Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.” NCT04214821 ↗1“Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.” NCT04212429 ↗ |
| Known as | Levofloxacin hydrochloride | “Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.” NCT02439632 ↗ |
| Known as | Levofloxacin Ocular Implant | “Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.” NCT05441930 ↗ |
| Known as | Levofloxacin Ophthalmic Solution | “Levofloxacin Ophthalmic Solution” NCT03519516 ↗ |
| Known as | levofloxacin tablets | “The experimental group receives Sanjin tablets plus levofloxacin tablets (LT) placebo” PMID 31324199 ↗ Jul 2019 |
| Known as | LFX | “Levofloxacin (LFX) and moxifloxacin (MXF) are the two most frequently recommended fluoroquinolones for treatment of patients with multidrug-resistant tuberculosis (MDR-TB).” PMID 23927582 ↗ Oct 20132“6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen” NCT07198685 ↗ “The FQs - sensitive group was treated with the BDLL regimen (bedaquiline (BDQ), delamanid (DLM), linezolid (LZD), and levofloxacin (LFX))” NCT07126639 ↗ |
| Known as | LVFX | “In vitro studies have suggested the corneal cytotoxicity of third-generation fluoroquinolone levofloxacin (LVFX) and fourth-generation fluoroquinolone moxifloxacin...” PMID 21060669 ↗ Oct 20101“levofloxacin [LVFX]” NCT02365623 ↗ |
| Known as | MP-376 | “OBJECTIVES: This study assessed the efficacy and safety of a novel aerosol formulation of levofloxacin (MP-376, Aeroquin) in a heavily treated CF population with PA infection.” PMID 21471106 ↗ Feb 20114“MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery.” NCT01180634 ↗ “MP-376 (Levofloxacin solution for Inhalation)” NCT00752414 ↗ “MP-376 (Levofloxacin solution for Inhalation)” NCT00503490 ↗ “MP-376 (Levofloxacin solution for Inhalation)” NCT00840333 ↗ |
| Known as | PRO-174 | “* PRO-174. Levofloxacin 0.5% ophthalmic solution.” NCT03519516 ↗ |
| Known as | Quixin | “Groups 1, 2 and 3 received topical ofloxacin 0.3% (Ocuflox), ciprofloxacin 0.3% (Ciloxan) and levofloxacin (Quixin) respectively;” PMID 18211932 ↗ Jan 2008 |
| Known as | Tavanic | “Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.” NCT00495339 ↗3“(Tavanic ''levofloxacin 500 mg'') [Sanofi-Aventis - Egypt]” NCT03038321 ↗ “levofloxacin (Tavanic) orally or no antibiotics” NCT04212403 ↗ |
| Modality | Small molecule | “a fluoroquinolone” NCT00376376 ↗ |
| Route | Oral | “Patients receive oral levofloxacin once daily for 7 consecutive days” NCT00005590 ↗ |