Although the indication is the evidentiary basis for a claim such as “Proven efficacy”, the statements, “Indicated in condition X” and “Proven efficacy in condition X”, are not equivalent.
The message “Indicated in condition X” is a legal statement setting the parameters around marketing and clinical use. As such, lowest level fair balance is sufficient.
The statement “Proven efficacy in condition X” is not a simple legal statement; it is a therapeutic claim. In HCP advertising, APS containing therapeutic claims (e.g. efficacy, effectiveness, safety, tolerability) are required to disclose the highest level of fair balance.