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  • 1.  505b2 RLDs

    This message was posted by a user wishing to remain anonymous
    Posted 08-Sep-2022 08:15
    This message was posted by a user wishing to remain anonymous

    Is it feasible in a 505b2 application to cite two (or more) RLDs (reference listed drugs)?  Examples?


  • 2.  RE: 505b2 RLDs

    Posted 09-Sep-2022 08:38
    I don't know of any specific examples, but I can think of no reason why you couldn't reference two or more listed drugs. The 505(b)(2) guidance gives a lot of examples of what can be submitted as a 505(b)(2) application. The fact that it doesn't include your idea doesn't mean that it is not possible.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: 505b2 RLDs

    Posted 09-Sep-2022 13:21
    It is possible and acceptable, especially if the 505B2 product is a new combination of 2 or more approved products.  If it is only a single ingredient product, I think you need to only reference one RLD, the one most appropriate to your new product.

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    Michael Hamrell, Ph.D., RAC, FRAPS
    Nipomo CA
    United States
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    Original Message


  • 4.  RE: 505b2 RLDs

    Posted 26-Sep-2022 18:21
    Yes, it is feasible and acceptable to cite two or more LDs in a 505(b)(2) application (FYI, we usually use the term "LD" instead of "RLD" when discussing 505(b)(2) products; RLD is typically used when discussing generic products). The main thing you need to keep in mind is that you need to be able to establish a scientific bridge to every LD you intend to rely upon in your NDA. How you establish each bridge (e.g., comparative bioavailability study, bioequivalence study, biowaiver, etc.) will depend on your product and the LD.

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    Marissa Berry, Ph.D., RAC
    Senior Manager, Regulatory Strategy
    Durham, NC
    United States
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    Original Message


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