Posted by Michael Wonder on 05 Feb 2019
FDA accepts for review new drug application for Merck’s investigational combination of imipenem/cilastatin and relebactam, and supplemental NDA for Zerbaxa (ceftolozane and tazobactam)
5 February 2019 - Merck today 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 (MK-7655A, IMI/REL), 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 (ceftolozane and tazobactam) 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 16 July 2019, while the PDUFA target action date for Zerbaxa is 3 June 2019.
