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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Use of Brand Name for combination product

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • F Offline
    F Offline
    Fernand
    wrote on last edited by
    #1

    "Product A just received approval for new indication to be used in combination with Product B. The indication reads :

    Product A (brand name) in combination with product B (generic name) is indicated for first-line treatment of....

    When using Product A (brand name) in combination with product B (generic name), consult product monograph for Product B (Brand name) for further information on this drug.

    Q: would we be able to use Product B's brand name and logo in the APS?"

    Jennifer CarrollJ 1 Reply Last reply
    0
    • F Fernand

      "Product A just received approval for new indication to be used in combination with Product B. The indication reads :

      Product A (brand name) in combination with product B (generic name) is indicated for first-line treatment of....

      When using Product A (brand name) in combination with product B (generic name), consult product monograph for Product B (Brand name) for further information on this drug.

      Q: would we be able to use Product B's brand name and logo in the APS?"

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      @fernand

      If Product B is owned by the same sponsor as Product A, use of the brand name and logo is considered co-promotion. It may be used in the APS based on Product A’s indication but will require indication and fair balance for Product B at a minimum. Requirements will be determined by the content in the APS.

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      • F Offline
        F Offline
        Fernand
        wrote on last edited by
        #3

        Thank you for your response. Would this still apply if Product B did not have the indication? or if the indication is expected soon?

        Jennifer CarrollJ 1 Reply Last reply
        0
        • F Fernand

          Thank you for your response. Would this still apply if Product B did not have the indication? or if the indication is expected soon?

          Jennifer CarrollJ Offline
          Jennifer CarrollJ Offline
          Jennifer Carroll
          wrote on last edited by
          #4

          @fernand

          Our previous response was provided with the understanding that Product B had a similar indication.

          Where Product B does not have an indication at all, there can be issues with potential off-label promotion. It would be suggested to not use the Product B logo in Product A advertising in those cases. Use of Product B’s brand name could be considered when presented in the context of the PM for Product A, i.e. in a cautionary manner only. It should not be designed as co-promotion of Product B. As the respective indications and PM dictate how Product A and B can be presented, we suggest submitting for an opinion with the PMs as there may be nuances within that may not be addressed as a general question.

          Eg. Product A is indicated for combination use with Product B for metastatic melanoma. Product B has no metastatic melanoma indication at all. If the APS is highlighting use in metastatic melanoma and includes Product B’s logo, this would be considered off-label promotion for metastatic melanoma as Product B has no such indication.

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