OPDP Flags Efficacy Webpage With Untitled Letter
April 4, 2025 at 11:45 AM EST
The FDA’s Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to Taiho Oncology Inc. in Princeton, New Jersey, alleging a webpage for its Lytgobi (futibatinib) tablets made false or misleading representations about the product’s benefits.
The March 21 letter noted Lytgobi was approved under the accelerated approval pathway and that the FDA requires sponsors o... Read More
