The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Delafloxacin will be available as both tablets and for injection. It was approved with a boxed warning for serious adverse reactions including possibly permanent tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
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