![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
EU WC
Listed Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
SUL-DUR is an IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV BLI, being developed for the treatment of infections caused by ABC, including carbapenem-resistant strains.
Lead Product(s): Sulbactam,Durlobactam,Imipenem
Therapeutic Area: Infections and Infectious Diseases Product Name: SUL-DUR
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
Sulbactam-Durlobactam (SUL-DUR) is an IV, investigational drug that is combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, novel broad-spectrum IV BLI, developed for treatment of infections caused by ABC complex, including carbapenem-resistant strains.
Lead Product(s): Sulbactam,Durlobactam,Imipenem
Therapeutic Area: Infections and Infectious Diseases Product Name: ETX2514sul
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2022
Details:
FDA has approved sNDA for RECARBRIO (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Lead Product(s): Imipenem,Cilastatin,Relebactam
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), in the primary and key secondary endpoints of the study.
Lead Product(s): Imipenem,Cilastatin,Relebactam
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2020
Details:
The submission is based on the results of the pivotal Phase 3 RESTORE-IMI 2 trial in adult patients with HABP/VABP.
Lead Product(s): Imipenem
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2020