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Regulatory/FDA

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Dec. 14, 2020 – In a recent Untitled Letter, the FDA’s Office of Prescription Drug Promotion (OPDP) states that claims made by Azurity Pharmaceuticals Inc. in a healthcare professional email for XATMEP® (methotrexate) oral solution indicate that Azurity “appears to be promoting Xatmep without presenting the serious risks of the drug in a truthful and […]

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Regulatory/FDA

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

Nov. 2, 2018 – Providing information about a drug product’s benefits without including any risks is an issue that the FDA’s Office of Prescription Drug Promotion (OPDP) does not take lightly, as evidenced by an Oct. 22 Warning Letter from OPDP to Vanda Pharmaceuticals Inc. This Warning Letter is the second Warning Letter issued in […]

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