COMPLICATED URINARY TRACT INFECTIONS


Associated tags: Research, Meropenem, NDA, Infectious Diseases, Urinary tract infection, Patient, Prescription Drug User Fee Act, Pharmaceutical industry, Pyelonephritis, Food, Medicine, PDUFA, Infection, Pharmaceutical, FDA, Science, Health, AP, ESBL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration

Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

Retrieved on: 
Friday, February 23, 2024
Research, Infectious Diseases, FDA, Hospitals, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Urinary tract infection, CRL, New Drug Application, Multimedia, Chemistry, Food, Pyelonephritis, Symantec Endpoint Protection, Patient, Medicine, Melinta Therapeutics, Medication, NDA, CMC, Pharmaceutical industry

This press release features multimedia.

Key Points: 
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240223169844/en/
    The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam.
  • The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
  • “While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam.

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Thursday, November 9, 2023
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Wellcome Trust, Government, FDA, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Meropenem, PDUFA, Food, Cutis laxa, United States Department of Health and Human Services, Pyelonephritis, Melinta Therapeutics, End-user license agreement, Prescription Drug User Fee Act, Human services, Regulation of tobacco by the U.S. Food and Drug Administration, Urinary tract infection, R, Administration, QIDP, CDC, Pseudomonas aeruginosa, Regulation, Medicine, Partnership, Infection, AP, ESBL, NDA, License, Therapy, Patient, Bangladesh Technical Education Board, Pharmaceutical industry

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults

Retrieved on: 
Tuesday, August 15, 2023
Health, FDA, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Priority review, Senior, Pyelonephritis, Medicine, Infection, New Drug Application, NDA, Cutis verticis gyrata, Prescription Drug User Fee Act, Cutis, Medication, Urinary tract infection, Genetically modified bacteria, Patient, Test, PDUFA, Viral, Meropenem, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.

Key Points: 
  • The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.
  • The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 22, 2024.
  • “The NDA acceptance represents the culmination of unwavering dedication, scientific excellence, and the collaborative efforts of our talented team, partners, and clinical investigators,” said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • “Patients with cUTIs, including pyelonephritis, and their healthcare providers should have a new treatment option when confronted with infections due to these antibacterial resistant infections.”