Tags : Imipenem


Merck Reports Results of Recarbrio (imipenem/cilastatin/relebactam) in P-III RESTORE-IMI 2

Shots: The P-III RESTORE-IMI 2 study involves assessing of Recarbrio (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) vs Piperacillin/Tazobactam in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) The P-III RESTORE-IMI 2 study resulted in meeting its 1EPs & 2EPs of statistical non-inferiority           in Day 28 all-cause mortality and […]Read More


Merck’s Recarbrio (imipenem/cilastatin/relebactam) Receives the US FDA’s Approval for Complicated

Shots: The US FDA approval is based on clinical safety and efficacy data of Recarbrio (injection, 1.25gm) approved for cUTI including pyelonephritis, caused by certain Gram-negative microorganism and also indicated for patients with cIAI aged 18yrs.+ who have limited or no alternative treatment options The US FDA reviewed its NDA under Qualified Infectious Disease Product […]Read More


Merck Reports Acceptance of NDA from FDA for Its (Imipenem/Cilastatin)

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 […]Read More