FDA Approves New Antibiotic for Skin Infections

The US Food and Drug Administration has approved Baxdela (delafloxacin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria in adult patients.

Baxdela is a fluoroquinolone that can be administered in tablet form or intravenously without regard to food. The antibiotic works against both gram-positive and gram-negative pathogens, including methicillin-resistance Staphylococcus aureus. Currently, there are no anticipated drug-drug interactions, aside from co-administration with chelating agents, such as antacids.
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Common adverse reactions reported in patients treated with Baxdela include nausea diarrhea, headache, transaminase elevations, and vomiting. In addition, fluoroquinolones have been associated with tendonitis and tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbations of myasthenia graces.

Patients with a history of myasthenia graves should not be prescribed Baxdela, and patients who exhibit signs of hypersensitivity should discontinue treatment.

—Melissa Weiss


Melinta Therapeutics announces U.S. FDA approval of BexdelaTM (delafloxacin) for acute bacterial skin and skin structure infections (ABSSSI) [press release]. New Haven, CT: Melinta Therapeutics; June 19, 2017. Accessed June 20, 2017.