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  • 1.  New Dosing Regimen

    This message was posted by a user wishing to remain anonymous
    Posted 07-Dec-2017 16:44
    This message was posted by a user wishing to remain anonymous

    Dear Community-

    Can a new dosing regimen (BID vs QD) be submitted as a sNDA to an approved NDA or does it require a separate NDA?

    Thanks for your help!


  • 2.  RE: New Dosing Regimen

    Posted 08-Dec-2017 05:20
    If the formulation changes and clinical studies were required to demonstrate efficacy and safety of the new formulation, a new NDA is required.  If it is a result of new understanding of PK/PD and clinical performance of the same formulation, an sNDA would be appropriate.

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


  • 3.  RE: New Dosing Regimen

    Posted 08-Dec-2017 11:27
    ​If the formulation associated with the new dosing regimen involves a new dosage form (for example tablets to capsule or oral dosage to injectable etc...), then the FDA would recommend a new NDA.

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    GRSAOnline
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    Original Message


  • 4.  RE: New Dosing Regimen

    Posted 27-Dec-2017 18:00
    Changes to dosing regimen will require a 505b2 application. 

    https://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf Page 5 of guidance document.

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    Amit Jain

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    Original Message


  • 5.  RE: New Dosing Regimen

    This message was posted by a user wishing to remain anonymous
    Posted 28-Dec-2017 09:38
    This message was posted by a user wishing to remain anonymous

    ​The question was related to an already approved NDA! 505(b)(2) situation applies only if the patent for the original API/exclusivity for original NDA expires........
    Original Message


  • 6.  RE: New Dosing Regimen

    Posted 28-Dec-2017 10:34
    In that case: You need to submit Prior Approval Supplement to the Agency to remove or modify the currently approved recommended dosage regimen and include a new recommended dosage regimen. Per changes to approved NDA 7 ANDA: X.B.(1)
    In your application you need to provide pharmacokinetics analyses and dose/exposure-response analyses demonstrating the comparability of the pharmacokinetics exposure, safety, and efficacy of the proposed new dosing regimen with the previously approved regimen.

    Hope this helps.

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    Amit Jain

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    Original Message


  • 7.  RE: New Dosing Regimen

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2017 09:09
    This message was posted by a user wishing to remain anonymous

    ​The question was related to an already approved NDA! 505(b)(2) situation applies only if the patent for the original API/exclusivity for original NDA expires........
    Original Message


  • 8.  RE: New Dosing Regimen

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2017 09:09
    This message was posted by a user wishing to remain anonymous

    ​Please read carefully all the answers, you are just too late with your response. Glen Park has already answered in the case of only dosing regimen change, sNDA was recommended. GRSAOnline has recommended a new NDA if dosing regimen change is also accompanied with dosage form change i.e. new dosage form.

    Original Message


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