Article 48NEH Antibiotics: FDA accepts review regulatory filings for Merck investigational combo drug and ZERBAXA®

Antibiotics: FDA accepts review regulatory filings for Merck investigational combo drug and ZERBAXA®

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Merck announced this week that the U.S. Food and Drug Administration (FDA) has accepted for review regulatory filings for two antibacterial agents. These filings are: (1) a NDA accepted for Priority Review for the combination of relebactam, the company's investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated ["]

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