Merck Reports Acceptance of NDA from FDA for Its (Imipenem/Cilastatin) + (Relebactam) for Complicated Urinary Tract and Intra-Abdominal Infections in Adults


  • 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)

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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at

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