Joint Meeting of the FDA's Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee November 5, 2015
Purpose of Today’s Meeting
• To discuss the benefits and risks of the systemic fluoroquinolone antibacterial drugs for the following indications given the scientific advances in clinical trials and the safety profile that has emerged over the lifecycle of these drugs:
– Acute bacterial sinusitis (ABS)
– Acute bacterial exacerbation of chronic bronchitis (ABECB)
– Uncomplicated urinary tract infections (uUTI)