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  • 1.  Can we use excipients as active ingredient for drug registration?

    Posted 25-Sep-2013 05:21
    We have product which requires inactive ingredients (from FDA ingredient lists) to be used for active ingredient.   Can we use it?  If so, how do we fill CTD substances part?  Do we have to fill all CTD parts?

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    Eugene Lee
    Taejoon Pharm
    Seoul
    Korea, Republic of
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  • 2.  RE:Can we use excipients as active ingredient for drug registration?

    Posted 25-Sep-2013 13:35

    Dr. Lee:

    You potentially can use any molecule as an active ingredient.  However, if the particular ingredient has never been used as an active ingredient, you should confirm with FDA whether the particular use to which you want to put the ingredient will require additional non-clinical studies to support the ingredient's safety.  And, of course, you will also need to prove that the ingredient is effective as an active ingredient.

    Best of luck,

    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
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    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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    Original Message


  • 3.  RE:Can we use excipients as active ingredient for drug registration?

    Posted 25-Sep-2013 15:21
    Hello Lee,

    I agree with Michael, you can use excipient as an active moeity, but your question here is not fully clear, As far as i understand for registration/filing that will depend on the "indication" and "product category" you labeled on your product.

    It would be helpful if you provided more specific information.

    Best Regards

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    Amit Jain
    United States
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    Original Message


  • 4.  RE:Can we use excipients as active ingredient for drug registration?

    Posted 25-Sep-2013 20:14

    Dear Lee,

    You can very well use an inactive that was listed on FDA IIG database as an active ingredient. There are few products where inactive was found effective for a particular condition and was later approved by the FDA. Sodium benzoate is one example. 

    In eCTD, you ignore 3.2.P.4 as you claim inactive as active and complete rest of the sections in Module 3 accordingly.

    Hope this helps!!! 
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    Vikram Katragadda RAC
    Senior Scientist
    Lawrenceville NJ
    United States
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    Original Message