Delafloxacin sold under the brand name Baxdela among others, is a fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections. It was developed by Melinta Therapeutics. Chemically it is an anionic fluoroquinolone with structural modifications that enhance activity in acidic environments and improve potency against Gram positive pathogens including methicillin resistant Staphylococcus aureus. Available in intravenous and oral formulations, typical clinical dosing uses a 300 mg IV infusion every 12 hours or a 450 mg oral tablet every 12 hours for approved indications, with bioavailability and pharmacokinetic profiles supporting interchange between routes in many patients. The mechanism is bactericidal inhibition of bacterial type II topoisomerases, including DNA gyrase and topoisomerase IV, and the compound is eliminated by combined renal and hepatic pathways; safety monitoring follows class guidance for fluoroquinolones including attention to tendinopathy, neuropathy, and QT interval when warranted.
Parent: Delafloxacin
Delafloxacin API and finished-product control strategies focus on identifying and limiting process related and degradation impurities such as N-oxide species, desalkyl and dehalogenated derivatives, lactam or ring-opened degradation products, and specified synthetic intermediates; typical analytical control uses validated HPLC, LC-MS and related compound standards. In practice specified related compounds are assigned individual limits commonly in the range of 0.05 to 0.20 percent by weight, with total organic impurities commonly controlled to not exceed about 0.5 percent, and established identification thresholds aligned with ICH Q3A/Q3B principles; assay acceptance criteria for the active substance are generally set to ensure potency near label claim, for example 98.0 to 102.0 percent, with tighter limits for finished-dose products as required by product specification. Actual impurity names and numerical limits vary by manufacturer and regulatory submission and must be taken from the approved specification and certificate of analysis for the specific batch.
Delafloxacin is used to treat acute bacterial skin and skin structure infections, including cases caused by susceptible Gram positive and Gram negative organisms; use should follow susceptibility data and approved labeling.
Delafloxacin is bactericidal and inhibits bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication and cell division; its chemical properties confer enhanced activity in acidic environments and improved potency against certain Gram positive pathogens.
Delafloxacin is regarded as a later generation fluoroquinolone with expanded Gram positive activity compared with earlier agents, often described clinically as an advanced or fourth generation type due to its spectrum and structure.
Cost varies by country, formulation, distributor and insurance coverage; branded Baxdela in the United States has historically been associated with several hundred to over a thousand dollars for a full treatment course depending on dose and supplier, while hospital purchasing agreements, discounts and any available generic alternatives will affect actual patient or payer cost. For current pricing consult a pharmacy, wholesaler or official distributor.
