Cipher Pharmaceuticals: ConZip (tramadol hydrochloride)
FDA warning letter, 24 August 2017. A professional detail aid for ConZip extended-release capsules made efficacy claims but included no risk information. FDA also said it left out the full approved indication and its important limitations of use.
The letter
- Date
- 24 August 2017
- Type
- Warning letter
- Product
- ConZip (tramadol hydrochloride)
- Promoted piece
- Professional detail aid (CNZSA03201402)
- Aimed at
- Healthcare professionals
- Format
- Sales aid or visual aid
- Came in under Form FDA 2253
- Yes, the letter says it was submitted on Form FDA 2253
- 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
“However, the detail aid fails to communicate any risk information about the product.”
- Missing required disclosure
“the detail aid is misleading because it fails to provide material information regarding ConZip’s full FDA-approved indication, including important limitations of use.”
Check your claims before FDA does
Arca reads a promotional piece against the approved labeling and the references it cites, and flags each claim the label does not support. See how Arca supports MLR review. Back to the OPDP letter search.