FDA approves Baxdela to treat acute bacterial skin infections

The FDA announced today that it has approved Baxdela to treat acute bacterial skin and skin structure infections.

Baxdela (delafloxacin, Melinta Therapeutics) is an antibacterial drug available for intravenous and oral use, according to a news release from the FDA.

Nausea, diarrhea, headache, transaminase elevations and vomiting were the most common adverse reactions.

Baxdela, like all fluoroquinolones, has a boxed warning alerting 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, according to the FDA. It is contraindicated for patients with hypersensitivity to fluoroquinolones.

Delafloxacin received a qualified infectious disease product (QIDP) designation from the FDA, which is given to antibacterial products to treat serious or life-threatening infections, according to the release. It was given priority review as part of the QIDP designation, and also received fast track designation, according to the release.

Reference: www.fda.gov

Editor's note: This article has been revised to reflect that the boxed warning alerts of increased risk of disabling and potentially irreversible serious adverse reactions, and to clarify that the product contraindication is not part of the boxed warning. The editors regret the error.