DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted a priority review for CONTEPO™ (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the CONTEPO NDA is June 30, 2019. In addition to priority review, CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.
In the NDA acceptance letter, the FDA stated that no filing or potential review issues were identified. In addition, the Agency stated that it has not referred CONTEPO to an advisory committee meeting at this time.