553 - Can you use "New" in APS for a product that has been on the market but has had their indication revised/expanded?

  • Terms related to or suggesting “new” should be restricted to one year post marketing (Code section 11). If there is a change to the terms or market authorization that changes the products scope, it can be used for one year post the change, however, the copy should be clearly limited to the feature that is new (i.e. “new data”, “new indication in population X”). As an example, addition of an indication in pediatrics, should be clearly limited to this population, not a broad and open statement of “new”. Similarly, a revision to the indication which creates a greater restriction on the use of the product, should not be positioned as a “new” indication, but as a new restriction on use.