Merck’s Recarbrio (imipenem/cilastatin/relebactam) Receives the US FDA’s Approval for Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections

Merck’s Recarbrio (imipenem/cilastatin/relebactam) Receives the US FDA’s Approval for Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections

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 (QIDP) designation for cUTI and cIAI and has received PR designation
  • Recarbrio is a triple combination therapy comprising of Imipenem (penem antibiotic), cilastatin sodium (renal dehydropeptidase inhibitor) and relebactum (beta-lactamase inhibitor) and is expected to be available in the US in H2’19

Click here to read full press release/ article | Ref: Merck | Image: The Times Herald