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Delafloxacin: First Global Approval

Anthony Markham1

  • 1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|July 28, 2017
PubMed

Insights

Delafloxacin is a novel fluoroquinolone antibiotic approved for acute bacterial skin infections. This summary outlines its development milestones leading to this significant regulatory approval.

Area of Science:

  • Pharmacology
  • Infectious Diseases
  • Drug Development

Background:

  • Delafloxacin is a fluoroquinolone antibacterial agent.
  • It exhibits activity against Gram-positive and Gram-negative pathogens.
  • Melinta Therapeutics is developing delafloxacin for various bacterial infections.

Purpose of the Study:

  • To summarize the development milestones of delafloxacin.
  • To highlight the path to its first global approval.

Main Methods:

  • Review of development history.
  • Summary of key regulatory and clinical events.

Main Results:

  • Delafloxacin received US FDA approval in June 2017.
  • Approval was for the treatment of acute bacterial skin and skin structure infections.

Conclusions:

  • Delafloxacin represents a new therapeutic option for bacterial skin infections.
  • The drug's development journey culminated in a significant regulatory milestone.

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