Achaogen, Inc. announced that the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee voted on the two points for Advisory Committee consideration as follows: The FDA is not bound by the Committee's votes but takes its input into consideration when reviewing marketing applications. Plazomicin has a Prescription Drug User Fee Act (PDUFA) date of June 25, 2018. If the FDA approves plazomicin by this target action date, Achaogen expects to launch plazomicin in the U.S. soon thereafter. Plazomicin is an aminogly coside that was developed to treat serious bacterial infections due to multidrug resistant gram-negative bacteria including carbapenem-resistant Entero bacteriaceae(CRE), and has been evaluated in two Phase 3 clinical trials, EPIC and CARE. MDR gram-negative bacteria are a type of bacteria with resistance to multiple antibiotics. They can cause bacterial infections that pose a serious threat for hospitalized patients. The problem is extensive and growing; the Centers for Disease Control and Prevention (CDC) characterized CRE as “nightmare bacteria” and an immediate public health threat that requires “urgent and aggressive action”. Patients with MDR infections often have limited or inadequate therapeutic options leading to high rates of mortality.