Long-Term Drug Shortage – Zerbaxa® (ceftolozane/tazobactam)
Enforcement Report - Week of January 13, 2021
Enforcement Report - Week of January 6, 2021
Health Canada Issues Recall Merck Canada Inc`s Zerbaxa
The combination of ceftolozane with tazobactam broadens the range of antibiotic therapy in adults with severe infections of the lungs, the urinary tract, the renal pelvis and the abdominal cavity. In view of the increasing resistance development in bacteria, this drug combination is therefore an important additional treatment option.
Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Zerbaxa 3g dose (ceftolozane and tazobactam) for an additional indication for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents
The U.S. Food and Drug Administration has approved Merck & Co Inc's combination treatment for complicated forms of urinary tract and abdominal infections, the drugmaker said on Wednesday.
Merck & Co. is one of the few large drugmakers still pursuing antibacterial R&D, and on Wednesday, the company scored approval for a combo drug that tackles serious urinary tract and abdominal infections when other treatments don't work.
Merck hasn’t exactly made a fortune on its $9.5 billion Cubist Pharmaceuticals buyout, but now, a next-generation antibiotic it acquired in that deal has a brand-new indication that could help jump-start sales.
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of results from ASPECT-NP, a randomized, double-blind, multi-center Phase 3 clinical trial evaluating the efficacy and safety of ZERBAXA® (ceftolozane and tazobactam) for the treatment of adult patients with ventilated nosocomial (hospital acquired) pneumonia. The results demonstrated non-inferiority of an investigational dose of ZERBAXA to meropenem, the active comparator, in the primary and key secondary endpoints. Based on these results, Merck has submitted supplemental new drug applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking regulatory approval for ZERBAXA for this potential new indication. The FDA Prescription Drug User Fee Act (PDUFA) date is June 3, 2019. Detailed findings of the ASPECT-NP Phase 3 trial are scheduled to be presented at the 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), on Monday, April 15 at 1:30 pm local time in Amsterdam, Netherlands (Poster P1917)