Xeloda Labeling Updated Under FDA’s New Program for Older Oncology Drugs
Project Renewal is an Oncology Center of Excellence initiative that aims to update the labeling information for certain older oncology drugs.
Project Renewal is an Oncology Center of Excellence initiative that aims to update the labeling information for certain older oncology drugs.
The table provided is a review of notable updates that occurred in November 2022 for investigational products in development.
LB1148 is a broad-spectrum serine protease inhibitor designed to neutralize digestive enzymes and potentially reduce intestinal damage.
The designation is supported by data from the 12-week, randomized, double-blind phase 2 FILLMORE trial.
Positive topline results were announced from a phase 3 trial evaluating glepaglutide in patients with short bowel syndrome.
Vegzelma is a vascular endothelial growth factor inhibitor.
Konvomep contains 2mg of omeprazole, a proton pump inhibitor, and 84mg of sodium bicarbonate per mL after reconstitution.
The decision to remove Zelnorm from the market was strictly a business decision.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
Familial adenomatous polyposis is caused by abnormalities in the APC gene.