Product Sponsor Goal PDFUA Date Indication
Contepo (fosfomycin) 2020-06-19 Injectable formulation of the epoxide antibiotic with dosing regimen to optimize pharmacokinetics and pharmacodynamics for I.V. treatment of complicated urinary tract infections (cUTI)
MenQuadfi (meningococcal vaccine*) 2020-04-25 Meningococcal (groups A, C, Y, W) polysaccharode tetanus toxoid conjugate vaccine for prevention of meningococcal meningitis in patients two years of age and older
Recarbrio (relebactam, cilastatin and imipenem)

2020-06-04 New indication for the beta lactamase inhibitor and antibiotic combination for treatment of adults with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)