Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025
The FDA Law Blog
APRIL 13, 2025
By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). This letter, dated March 21, 2025, cites Taihos false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act.
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