The FDA accepted a New Drug Application (NDA) for the combination of relebactam with imipenem-cilastatin (IMI/REL, Merck) for the treatment of complicated urinary tract infection (cUTI) and complicated intraabdominal infection (cIAI) caused by certain susceptible gram-negative bacteria, in adults with limited or no alternative therapies available.
The agency also agreed to consider a new indication for Merck’s ceftolozane-tazobactam (Zerbaxa) to treat adults with nosocomial pneumonia,