Merck announced that the U.S. 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, for the treatment of complicated urinary tract infections and complicated intra-abdominal infections caused by certain susceptible Gram-negative bacteria, in adults with limited or no alternative therapies available; and (2) a sNDA accepted for Priority Review for ZERBAXA to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by certain susceptible Gram-negative microorganisms. The Prescription Drug User Fee Act target action date for IMI/REL is July 16, 2019, while the PDUFA target action date for ZERBAXA is June 3, 2019.
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