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Merck: FDA Approves Recarbrio - Quick Facts

Drug maker Merck & Co. Inc. (MRK) said that the U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial.

The approval is for treatment of adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available.

Recarbrio is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections or cUTI.

This includes pyelonephritis, and other cUTIs caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Recarbrio is also indicated in patients aged 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections or cIAI, caused by certain susceptible Gram-negative microorganisms.

Merck noted that the approval of these indications is based on limited clinical safety and efficacy data for Recarbrio.

Relebactam received the FDA's Qualified Infectious Disease Product or QIDP designation for the treatment of cUTI and cIAI. The New Drug Application for Recarbrio received Priority Review designation from the FDA.

Merck said it expects to make Recarbrio available later this year.

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