NDAINTRAVENOUSPOWDERPriority Review
Approved
Nov 2019
Lifecycle
Peak
Competitive Pressure
0/100
Mechanism of Action
12.1 Mechanism of Action FETROJA is an antibacterial drug [see ] . 12.2 Pharmacodynamics The percent time of dosing interval that unbound plasma concentrations of cefiderocol exceed the minimum inhibitory concentration (MIC) against the infecting organism best correlates with antibacterial activity…
Indications (10)
older for the treatment of complicated urinary tract infections (cUTIs)including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coliKlebsiella pneumoniaeProteus mirabilisPseudomonas aeruginosaolder for the treatment of hospital-acquired bacterial pneumoniaventilator-associated bacterial pneumoniacaused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complexEscherichia coliEnterobacter cloacae complex
Loss of Exclusivity
LOE Date
Sep 3, 2035
115 months away
Patent Expiry
Sep 3, 2035
Exclusivity Expiry
Nov 14, 2029
Company
Shionogi
Japan - Osaka