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  • 1.  505(b)(2) Referencing a RS

    Posted 08-Jul-2017 19:39
    Hello Colleagues,

    Can a 505(b)(2) application reference an RS (an ANDA)and be used in a Bioequivalence bridging study when the RLD (a NDA) has been discontinued (not withdrawn due to safety or efficacy)?

    Thank you for your assistance.

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    David Lucking
    FL
    United States
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  • 2.  RE: 505(b)(2) Referencing a RS

    Posted 08-Jul-2017 20:23
    First, please explain how your proposed 505(b)(2) drug differs from the discontinued NDA? or your RS ANDA drug? In other words, why are you thinking of filing 505(b)(2) NDA instead of ANDA?

    Thanks

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    GRSAOnline
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    Original Message


  • 3.  RE: 505(b)(2) Referencing a RS

    Posted 08-Jul-2017 20:29
    ​If your question is can one file an ANDA referencing another currently approved ANDA since the original NDA is discontinued, I think yes you can.

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    GRSAOnline
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    Original Message


  • 4.  RE: 505(b)(2) Referencing a RS

    Posted 09-Jul-2017 11:06
    Hi David,

    RLD is not a must for 505(b)(2).  You can reference safety and efficacy info from published literatures and approved products.

    Best Regards,

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    Tyng-Yi (Tina) Lee MS RAC
    Consultant
    North Brunswick NJ
    United States of America
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    Original Message


  • 5.  RE: 505(b)(2) Referencing a RS

    Posted 10-Jul-2017 08:49

    To reference an approved drug, you do have to identify a specific product, which can be one that was discontinued for reasons other than safety or efficacy.  That said, there are a lot of caveats about what information you can reference and it worthwhile speaking to FDA if you plan a 505(b)(2).

    But, David, you asked whether, in a 505(b)(2), you could reference an ANDA drug when the RLD was no longer marketed?  No, I think you need to reference the original RLD.  I would call the review Division to ask this question, unless you intend to file another ANDA.



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    Glen Park
    Scynexis, Inc.
    Jersey City NJ
    United States
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    Original Message


  • 6.  RE: 505(b)(2) Referencing a RS

    Posted 09-Jul-2017 13:16
    David,

    Can a 505(b)(2) application reference an RS (an ANDA)and be used in a Bioequivalence bridging study when the RLD (a NDA) has been discontinued (not withdrawn due to safety or efficacy)?

    Before FDASIA 2012, FDA had allowed 505(b)(2) applicants to cite an ANDA as a listed drug. 

    Since then, FDA policy has evolved.

    FDA no longer allows such citation unless FDA grants an exception.

    Now per 21 CFR 314.54(a)(1)(iii), identification of the listed drug is required.  The term "listed drug" means a new drug product.  See 21 CFR 314.3(b) and FDCA 505(c) for 505(b)(2) purposes. 

    I would recommend you request Type B Meeting for discussion with the FDA.

    It is critical to understand current policy on ANDA and/or 505(b)(2) application requirements implemented under FDASIA 2012.  

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 7.  RE: 505(b)(2) Referencing a RS

    Posted 10-Jul-2017 22:07
    For 505(b)(2) bridging study you need "Listed Drug" for bioequivalence.

    RLD (Reference Listed Drug) and RS (Reference Standard) both are "Listed Drug".

    RLD and RS guidance for industries is exclusively for ANDA that was implemented since January 2017.

    But, in absence of physical sample of RLD, for 505(b)(2) bridging study RS can be utilized with prior approval of selection of RS based on available information from orangebook, in absence of RLD using controlled correspondence.

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    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Original Message


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