FDA approves new fluoroquinolone antibiotic to treat bacterial skin infections

The US Food and Drug Administration on Monday approved Baxdela (delafloxacin), a new antibacterial drug to treat acute bacterial skin and skin structure infections (ABSSSI). Developed by privately-held US biotech firm Melinta Therapeutics, Baxdela will be available for intravenous and oral use.

The most common adverse reactions associated with the drug were nausea, diarrhea, headache, transaminase elevations (an enzyme that is an indicator of liver injury) and vomiting. Baxdela, like all fluoroquinolones, has a Boxed Warning to alert health care professionals and patients of increased risk of disabling and potentially irreversible serious adverse reactions that have occurred together including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects, the FDA noted.Baxdela is contraindicated for patients with known hypersensitivity to fluoroquinolones.

Baxdela was designated as a qualified infectious disease product (QIDP). This designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.