File card for Avinza misleading
Pharma Compliance Alert, April 2, 2008
Ligand Pharmaceuticals' file card for Avinza "minimizes and fails to communicate important risk information for Avinza, fails to disclose the limitations to its indication, and makes numerous unsubstantiated efficacy claims for the drug," according to an FDA warning letter released March 26.
The file card fails to:
- Communicate and minimize risks associated with the drug's use
- Present the limitations to its approved indication
Furthermore, the card:
- Presents unsubstantiated efficacy claims
- Does not contain any information from the extensive Boxed Warning and Warnings sections in Avinza's approved product label
- Does not include information about the potential for abusing the product
- Does not disclose the limitations to the indicated use of Avinza
The FDA called the combination of the omission of serious, potentially fatal risks and unsubstantiated efficacy claims "egregious and alarming in its potential impact on the public health." The FDA is requesting the company stop using the file card.
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