Merck & Co, Inc., has announced FDA-approval of RECARBRIO (imipenem, cilastatin, and relebactam), a new combination antibacterial (injection 1.25 grams) indicated in patients 18 years of age and older who have limited, or no alternative treatment options, for complicated urinary tract infections (cUTIs), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
RECARBRIO, which Merck anticipates making available later this year, is also indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa.
Approval of these indications is based on limited clinical safety and efficacy data for RECARBRIO.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, Merck says RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Relebactam received FDA’s Qualified Infectious Disease Product (QIDP) designation for the treatment of cUTI and cIAI. The New Drug Application (NDA) for RECARBRIO received Priority Review designation from the FDA.
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