FDA approves new fluoroquinolone antibiotic to treat bacterial skin infections - Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today approved Baxdela (delafloxacin), a new antibacterial drug to treatacute bacterial skin and skin structure infections. Baxdela is available for intravenous and oral use.

The most common adverse reactions 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 alerthealth 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.

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.

As part of its QIDP designation, Baxdela was given priority review, which provides an expedited review of the drug’s application. In addition, Baxdela received fast track designation.

For more information, please visit: Baxdela