[{"orgOrder":0,"company":"Shionogi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Shionogi\u2019s sNDA with Priority Review for FETROJA\u00ae for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Shionogi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shionogi Announces FDA Approval of Fetroja\u00ae for Hospital-Acquired Bacterial Pneumonia AND Ventilator-Associated Bacterial Pneumonia","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Shionogi","sponsor":"Clinton Health Access Initiative","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements to Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Cefiderocol
The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programmes that ensure appropriate use. These provisions are especially important to avoid fuelling resistance to Fetroja (cefiderocol).
U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.