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# Materials Promote Unapproved Arog Drug: OPDP
- URL: https://www.fdaweb.com/materials-promote-unapproved-arog-drug-opdp/
- Published: 2018-07-11T12:00:00.000Z
- Updated: 2026-09-15T00:18:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141842

The CDER Office of Prescription Drug Promotion (OPDP) says that an Arog Pharmaceutical booth display and Web page for its investigational new drug Crenolanib besylate suggest that the drug is safe and effective for the purposes for which it is being investigated or otherwise promote the drug. A 6/28 [Notice of Violation](http://www.fda.gov/Downloabs/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivities/FDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM612977.pdf?ref=fdaweb.com) says the claims and presentations made on the booth display and Web page “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 FDA and whose safety and efficacy have not yet been established.”

The letter says the company describes Crenolanib as “a next-generation tyrosine kinase inhibitor for use in FLT3-mutated AML (acute myeloid leukemia).” It says that the booth display and Web page suggest that the drug has been established as being safe and effective in treating AML, in general when combined with chemotherapy at full doses. OPDP says the suggestion is particularly concerning given the lack of adequate safety and efficacy data about Crenolanib and the toxicity of current chemotherapy regimens and issues regarding the tolerability of such regimens. It also notes that the booth display did not include any information to indicate that Crenolanib is an investigational new drug that has not been approved for commercial distribution in the U.S. and that the booth appeared at an exhibit hall alongside approved products.

Arog was told to stop violating the Federal Food, Drug, and Cosmetic Act as discussed in the letter and respond with a list of violative promotional materials for which it will discontinue use.