FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Baxdela (delafloxacin)

Indication:

Acute skin and skin structure infections caused by certain aerobic gram-positive and gram-negative bacteria, including methicillin-resistant and methicillin-sensitive S aureus strains.

Mechanism:

Fluoroquinolone antibiotic; inhibits both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes, which are required for bacterial DNA replication, transcription, repair, and recombination.

Dosage:

300 mg IV q12hr for 5-14 days, OR

300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-14 days, OR

450 mg PO q12hr for 5-14 days

Approval:

Approval was based on two phase 3 trials in patients with acute bacterial skin and skin structure infections (ABSSSI) demonstrating that IV and oral delafloxacin monotherapy was statistically noninferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48–72 hr.

Reference:

Baxdela (delafloxacin) prescribing information. Melinta Therapeutics, Inc. Lincolnshire, IL. June 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/
208610s000,208611s000lbl.pdf

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.