Everest Medicines' Partner Venatorx Receives FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI)
Retrieved on:
Tuesday, August 15, 2023
Priority review, Pyelonephritis, Public, Infection, New Drug Application, NDA, Tuberculosis verrucosa cutis, Prescription Drug User Fee Act, AMR, Trial of the century, Urinary tract infection, MDR, HKEX, Patient, Test, PDUFA, Meropenem, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry
The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.
Key Points:
- The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.
- "We congratulate our partner for achieving this important milestone and bringing cefepime-taniborbactam a step closer to reaching patients confronted with antibacterial resistant infections.
- "In Asia, the challenges we are facing from MDR infections are more urgent and severe.
- The company is also actively developing other important antibacterial drug candidates for combating the increasing MDR infections in China and the rest of Asia.