Regulatory Open Forum

 View Only

  • 1.  Proprietary name request

    Posted 22-Mar-2024 06:50

    Dear all,

    Is it possible to file an NDA with a proprietary name that was not requested or approved beforehand by FDA? Will this impact the NDA review timline?

    Does the above applicable for ANDA as well?



    ------------------------------
    Moad Esa, M.Sc.
    Regulatory Affairs Manager
    ------------------------------


  • 2.  RE: Proprietary name request

    Posted 23-Mar-2024 09:41

    You have to submit the proprietary name request with the NDA regardless of whether the name had been submitted and conditionally approved earlier. During the IND phase, the review time is 6 months; during the NDA review, it's 3 months. The name isn't approved until the NDA is approved. 



    ------------------------------
    Beth Weinberg
    Regulatory Affairs Lead
    Cara Therapeutics Inc.
    Carmel IN
    United States
    ------------------------------

    Original Message


  • 3.  RE: Proprietary name request

    Posted 23-Mar-2024 10:41

    If you file an NDA without a conditionally approved proprietary name it will not impact the NDA review time, but may impact the labelling you receive upon approval. That is, the label may be approved without a proprietary name and you would have to amend the label with the name later. You will need to be prepared to submit the proprietary name request in the NDA filing or immediately after. As Beth notes, the initial review for a proprietary name is 6 months, but could be longer if the proposed name is not accepted and a new review cycle is initiated with the new proposed name. Below is an example of a label issued on approval for a product without an approved proprietary name.



    ------------------------------
    Glen Park PharmD
    Consultant
    Burien WA
    United States
    ------------------------------

    Original Message


Related Content