Regulatory Open Forum

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  • 1.  Changes to tablet shape

    Posted 13-Oct-2011 13:34
    Hi,

    I have an ANDA for an approved solid oral dosage form product.  The approved tablet is capsule-shaped.  How would I report a change in shape, say to round?  The strength, weight and color remain the same - the ONLY change is shape.  The Stabilities guidance mentions a change in size or strength, but I can't find anything specific for how to change from a capsule-shape to a round tablet.  Would that be considered size, and a PAS?

    Any ideas are much appreciated! 

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    Lisa Apolis RAC
    Alexandria VA
    United States
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  • 2.  RE:Changes to tablet shape

    Posted 14-Oct-2011 16:26

    i think you can make a case for a CBE type of supplement for this change, provided you can demonstrate no change in the release specifications for the product and that it does not impact stability (based on accelerated data).  the best bet might be to contact the ONDQ and ask their opinion.



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    Michael Hamrell, Ph.D., RAC, FRAPS
    Moriah Consultants
    Yorba Linda CA
    United States
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    Original Message


  • 3.  RE:Changes to tablet shape

    Posted 15-Oct-2011 18:20
    I am assuming that you are referring to a change in the shape of an immediate release tablet.  FDA Supac-IR questions and answers states the following:

    "Q: Are changes such as tablet shape and size covered under SUPAC-IR?
      A: In general, changes involving size and/or geometry of the tablet are not covered under SUPAC-IR, and would need prior approval supplements. However, changes in thickness due to a composition change may be covered under SUPAC-IR." 

    Here is the link:   http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124826.htm

    The information is under Miscellaneous toward the bottom.

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    Darlene O'Banion
    San Jose CA
    USA
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    Original Message