CytoDyn, Inc.

Warning LetterClosed

Antonio Migliarese Interim President and Chief Financial Officer CytoDyn, Inc. 1111 Main Street, Suite 660 Vancouver , WA 98660 United StatesIssued Feb 11, 2022The Office of Prescription Drug Promotion (OPDP)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: CytoDyn, Inc.
Location: Antonio Migliarese Interim President and Chief Financial Officer CytoDyn, Inc. 1111 Main Street, Suite 660 Vancouver , WA 98660 United States
FEI Number: N/A
Country: United States
Issue Date: February 11, 2022
Issuing Office: The Office of Prescription Drug Promotion (OPDP)
Product Type: Drugs
Status: Closed
Closeout Letter: July 25, 2023

Summary

CytoDyn, Inc. was cited for promoting leronlimab, an investigational drug not yet approved by the FDA, as safe and effective for COVID-19 treatment through a video interview featuring the company's leadership that was posted on its corporate website. The promotional video violated the Federal Food, Drug, and Cosmetic Act by making conclusory claims about the drug's safety and efficacy in a promotional context before those claims had been established through FDA approval or authorization. The FDA emphasized the public health concern posed by promoting an unapproved investigational drug for a serious disease that can cause respiratory failure and death, particularly during the COVID-19 pandemic emergency declaration.