Melinta Therapeutics Announces FDA Clearance of Antimicrobial Susceptibility Tests Concurrent with Baxdela Launch in the United States

Melinta Therapeutics announced today the U.S. Food and Drug Administration (FDA) has cleared three antimicrobial susceptibility tests (ASTs) that will be available to guide physicians towards the appropriate usage of Baxdela™ (delafloxacin). Baxdela, available in both intravenous and oral forms, is an FDA-approved fluoroquinolone indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria, with demonstrated in-vitro and clinical activity against Gram-positive and Gram-negative pathogens, including activity against MRSA (methicillin-resistant Staphylococcus aureus). The three ASTs that have been cleared are: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDiskTM), Liofilchem® Delafloxacin MIC Test Strip (MTS), and Thermo Scientific™ Sensititre™ MIC System.