2017年6月19日，由Melinta制药研发的新型抗生素delafloxacin（商品名：Baxdela）获美国食品药品监督管理局（FDA）批准上市，治疗由易感细菌引起的急性细菌性皮肤和皮肤结构感染。而到目前为止，该药已研发17年，Baxdela的成功获批，为治疗急性细菌性皮肤和皮肤结构感染(ABSSSI)的成人患者提供了一个新的选择。   由于细菌对现有抗菌药物的耐药性提高，急性细菌性皮肤和皮肤结构感染的治疗成为了难题，由耐甲氧西林金黄色葡萄球菌(MRSA)导致的发病率、并发症和住院率显著上升。   Baxdela是一种氟喹诺酮，能对抗包括MRSA在内的革兰氏阳性和革兰氏阴性病原体。它可以通过静脉注射和口服使用。   Baxdela新药申请(NDA)的批准得到了两个3期临床研究的支持。研究证明Baxdela静脉注射或口服的单疗法在FDA的48-72小时早期临床反应的主要终点上，并不次于万古霉素(vancomycin)和阿兹特龙(aztreonam)的结合疗法。除此之外，Baxdela有良好的耐受性，在3期临床中由副作用而导致的终止率只有0.9%   Baxdela为片剂和静脉注射剂，每瓶含有300mg德拉沙星（相当于433mg德拉沙星葡甲胺）；也可为口服片剂，包含450mg德拉沙星（相当于649mg德拉沙星葡甲胺）。推荐剂量为每12小时静脉注射一次，每次300mg或每12小时口服一次，每次1粒，持续5到14天。 Baxdela(Delafloxacin Injection, Tablets) BAXDELA Rx Generic Name and Formulations: Delafloxacin 450mg; tabs. Company: Melinta Therapeutics Select therapeutic use: Bacterial infections Indications for BAXDELA: Susceptible acute bacterial skin and skin structure infections (ABSSSI). Adult: ≥18yrs: 450mg every 12hrs for 5–14 days. ESRD (eGFR <15mL/min/1.73m2) or hemodialysis: not recommended (insufficient data). See full labeling. Children: <18yrs: not recommended. Warnings/Precautions: Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS effects); discontinue immediately if signs/symptoms occur. History of tendon disorders, peripheral neuropathy, or myasthenia gravis: avoid. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. Discontinue at 1st sign of skin rash, or any other hypersensitivity. Severe renal impairment receiving IV form: monitor serum creatinine levels, eGFR closely; consider switching to oral form if serum creatinine level increases. Discontinue if eGFR falls <15mL/min/1.73m2. Pregnancy. Nursing mothers. Ineractions: Separate dosing of oral form with magnesium- or aluminum-containing antacids, sucralfate, metal cations, multivitamins containing zinc or iron, or didanosine (buffered forms) by at least 2hrs before or 6hrs after these agents. Increased risk of tendinitis/tendon rupture with corticosteroids. For IV: avoid concomitant solution containing multivalent cations (eg, calcium, magnesium) through same IV line. See Also: Pharmacological Class: Quinolone. Adverse Reactions: Nausea, diarrhea, headache, transaminase elevations, vomiting, other CNS, cardiac, GI, metabolic, musculoskeletal, injection reactions (see full labeling); tendinitis/tendon rupture, peripheral neuropathy, hypersensitivity reactions, C. difficile-associated diarrhea. Generic Availability: NO How Supplied: Tabs—20; Blister packs—20 (2x10 tabs); Single-dose vials—10