Results Wire: US FDA Advisory Committee Supports Class Labeling Change and REMS for Systemic Fluoroquinolone Antibacterial Drugs – NOV 5, 2015 (AMDAC-DSRM)
On Thursday, November, 5, 2015, the Antimicrobial Drugs Advisory Committee (AMDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) reviewed data presented by the FDA and industry sponsors about the safety of fluoroquinolone antibacterial drugs as it pertains to their use in treatment of 3 indications: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infection (uUTI).
See the SAC Tracker report