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Home » Drug Claims at ASCO Meeting Lead to Enforcement Promotion Letter for Celator
Drug Claims at ASCO Meeting Lead to Enforcement Promotion Letter for Celator
September 14, 2016
Celator Pharmaceuticals has received a drug enforcement promotion letter as a result of a drug it showcased during the annual meeting of the American Society of Clinical Oncology (ASCO).
During the meeting, a panel discussed Celator’s product CPX-351 in treating cancer in general and patients with high-risk acute myeloid leukemia (AML). The product was touted as easily administered by users themselves. According to the FDA, the use of the drug as described requires the supervision of a physician.
In addition, Celator makes claims about the drug, including that “In vitro research has shown that a 5:1 ratio of cytarabine-daunorubicin delivers optimal anti-cancer activity.” None of the claims listed in the letter have been supported through human trials.
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