Shots:

• The NDA filing is based on the P-III RESTORE-IMI 1 study results- assessing Imipenem/Cilastatin + Relebactam (IMI/REL) vs imipenem/cilastatin + colistin (IMI+CST) in patients with gram-negative bacterial infections
• The P-III RESTORE-IMI 1 study were presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Madrid- Spain- in Aprl 2018 with its PDUFA date on 16 Jul-2019
• Relebactam IV is a class A and C beta-lactamase inhibitor and has received FDA’s FT designation in combination with imipenem/cilastatin for cUTI- complicated intra-abdominal infections (cIAI) & hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP)

  Ref: Business Wire | Image: Merck