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  • 1.  US Annual Reports for inactive or discontinued applications

    Posted 26-Jul-2012 09:18
    Our firm is in possession of the discontinued NDA and intellectual property rights for a drug product that is now manufactured for us under a third-party ANDA (we simply moved the proprietary name to the ANDA).  There is some difference of opinion as to whether or not we are still required to submit US Annual Reports for the discontinued NDA. 

    Some believe that requirement no longer applies once FDA moves the application to "inactive" status, while others assert that we are supposed to submit Annual Reports indicating no change.

    Can anyone shed some light on this question?  I would really appreciate reports of current practices (hopefully justified with a regulatory citation or guidance document).

    Thank you for your help.

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    Vincent Argiro
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  • 2.  RE:US Annual Reports for inactive or discontinued applications

    Posted 26-Jul-2012 12:27
    Vincent:

    When you say "Discontinued NDA" or "Inactive,"  did you mean to say that the said NDA has been withdrawn? If so, the case is closed.  No annual report.

    When a firm repeatedly fails to file annual reports, the NDA is also considered "being withdrawn."

    If you submit your annual report(s), you manifest the said NDA is not being withdrawn.  

    Thus, please act accordingly.     

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    www.RegulatoryDoctor.com
    Floyd VA
    United States
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    Original Message


  • 3.  RE:US Annual Reports for inactive or discontinued applications

    Posted 27-Jul-2012 08:53
    Hi Vincent,

    How was the NDA moved to an ANDA status?  Was a separate ANDA # assigned?  I have experience with NDAs that have a generic version but it was submitted under the NDA application number so the generic is listed under that number.  If the brand became inactive, annual reports would still be filed obviously to provide updates on the generic. 

    I hope this helps. 

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    Alison Trado
    Regulatory Affairs Manager
    Hill Dermaceuticals, Inc.
    Sanford FL
    United States
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    Original Message


  • 4.  RE:US Annual Reports for inactive or discontinued applications

    Posted 27-Jul-2012 11:06
    www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance>. The contact info is kind of hidden, but it's included here: www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053133.htm For small business inquiries, contact Brenda Stodart, Pharm.D. at 301/796.6707 or CDERSmallBusiness @ fda.hhs.gov (remove the spaces around the @).">You can get a quick answer from FDA Small Business Assistance at www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance>. The contact info is kind of hidden, but it's included here: www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053133.htm
    For small business inquiries, contact Brenda Stodart, Pharm.D. at 301/796.6707 or CDERSmallBusiness @ fda.hhs.gov (remove the spaces around the @).

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    Andrea Chamblee RAC, FRAPS
    Director
    FDA
    Rockville MD
    United States
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    Original Message


  • 5.  RE:US Annual Reports for inactive or discontinued applications

    Posted 31-Jul-2012 23:30
    I second Andrea' suggestion.  This is a great forum for many kinds of input, but this is a question I would address directly to FDA.  In this matter, their opinion is the only one that counts, and they don't need to cite a reference document to back it up.


    Julie Omohundro RAC
    RAQA Services
    Research Triangle Park NC
    United States




    Original Message