July 2018

Dear Dr. Puri-Lechner:
As part of its monitoring and surveillance program, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed Arog Pharmaceuticals lnc.’s (Arog) booth display for its investigational new drug Crenolanib besylate __________(b) (4) (Crenolanib) that appeared in the main exhibit hall at the American Society of Aematology’s (ASH) 59th Annual Meeting.1 We have also reviewed a webpage2 for Crenolanib titled, “Crenolanib A next-gen tyrosine kinase inhibitor for use in FL T3 -mutated AML.” The booth display and webpage suggest, in a promotional context, that Crenolanib, an investigational new drug, is safe and effective for the purposes for which it is being investigated or otherwise promote the drug. As a result, Crenolanib is misbranded under section 502(f)(1 ) of the Federal Food, Drug, and Cosmetic Act (FD&C) Act and in violation of section 301 (a) of the FD&C Act. The claims and presentations made on the booth display and webpage are concerning from a public health perspective because they make conclusory representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA and whose safety and efficacy have not yet been established.

Read the full Letter here.