Eisai: Fycompa (perampanel)
FDA untitled letter, 11 October 2018. An Eisai sales representative made oral statements to healthcare professionals about Fycompa. FDA said the statements suggested unapproved new uses and minimized the serious risks in the Boxed Warning, including psychiatric and behavioral reactions.
The letter
- Date
- 11 October 2018
- Type
- Untitled letter (OPDP)
- Product
- NDA 202834; 208277 Fycompa (perampanel) oral suspension, CIII Fycompa(perampanel) tablets, for oral use, CIII (NDA 202834)
- FDA matter number
- MA 352
- Promoted piece
- Sales representative oral statements during presentation to healthcare professionals
- Aimed at
- Healthcare professionals
- Format
- Spokesperson or influencer, Webinar or speaker program
- Came in under Form FDA 2253
- The letter does not say
- Bad Ad Program
- The letter says FDA also received a complaint through the Bad Ad Program.
- Close-out
- FDA's source does not say whether this letter was closed out.
What FDA cited
The categories below are this tool's labels, read from the letter. Each quote is FDA's own wording, copied from the letter.
- Omits or minimizes risk
“The presentation minimizes the serious risks associated with Fycompa and misleadingly suggests the drug is safer than has been demonstrated.”
- Broader use than approved
“the Eisai sales representative made statements that provide evidence that Fycompa is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.”
Check your claims before FDA does
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