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Recarbrio FDA Approval History

Last updated by Judith Stewart, BPharm on June 9, 2020.

FDA Approved: Yes (First approved July 16, 2019)
Brand name: Recarbrio
Generic name: imipenem, cilastatin, and relebactam
Dosage form: for Injection
Company: Merck
Treatment for: Urinary Tract Infection, Intraabdominal Infection, Nosocomial Pneumonia

Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

Development timeline for Recarbrio

DateArticle
Jun  5, 2020Approval FDA Approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
Jul 17, 2019Approval FDA Approves Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections
Feb  5, 2019FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam
Apr 22, 2018Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections

Further information

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