Advisory on Exclusivity Claims for Indications

[devadmin]

Expanding the approach to exclusivity claims

@Agency and @Manufacturer A new advisory has been posted on Exclusivity Claims for Indications. If you have any questions, please post below:

[NatBourre]

@admin Thank you for this advisory.

1. Does the font for the indication of product B need to be the same size as the font of product A?

2. If an APS mentions product A by brand name, is it acceptable to refer to product B by its generic name?

[Jennifer Carroll]

Hello @natbourre

1. No, but the indication size should be proportional to the claim size
2. Yes, it is acceptable to use the generic name.

[Boram]

@Jennifer-Carroll For the exclusivity claim, what level of FB would be required?

[Jennifer Carroll]

Hey @boram

The level of fair balance will be dependent on the exclusivity claim and any additional copy required to support it. For the exclusivity claims discussed in the above document, highest level fair balance would likely be required as these are indication comparisons. See Question 1 in Guidance on Fair Balance Level Selection and Placement