FDA Policy/General

Celator Investigational Drug Misbranded: OPDP

CDER’s Office of Prescription Drug Promotion (OPDP) says that a Celator convention exhibit hall panel on its investigational product CPX-351 (cytarabine, daunorubicin) liposome injection suggested that the drug is safe and effective for the purposes for which it is being investigated or otherwise promotes the product. An 8/25 Notice of Violation says there is no marketing authorization for CPX-351, (also known as Vyxeos) in the U.S. It is being studied as a treatment for therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes.

The letter says the panel described the use of CPX-351 in treating cancer in general and newly-diagnosed patients with acute myeloid leukemia specifically. “These uses are ones for which a prescription would be needed because they require the supervision of a physician and, therefore, for which adequate directions for lay use cannot be written,” OPDP says. “The claims and presentation, including the use of a proprietary name without any accompanying identification of the investigational drug product, make conclusions that the drug has been proven to be ‘optimal’ for the treatment of cancer and improves survival relative to ‘7+3’ chemotherapy in newly diagnosed patients with high-risk acute myeloid leukemia, when FDA has not approved CPX-351 for any use.”

The company was told to immediately stop its violative promotion and to respond with a plan for discontinuing use of violative materials.

This is the third letter issued by OPDP in 2016.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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