Drugs

Guide on Generic Drug Size and Shapes

FDA has released a final guidance entitled “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.” Under the guidance, the agency recommends that generic oral tablets and capsules intended to be swallowed intact should be of a similar size to the corresponding reference-listed drug (RLD). The agency (XXX LOWER-CASE XXX)recommends limiting size differences between therapeutically equivalent tablets as follows:

If the RLD is less than 17 mm in its largest dimension, the generic product should be no more than 20% larger than the RLD in any single dimension (the resulting single dimension of the generic should not exceed 17 mm). It should also be no more that 40% larger than the volume of the RLD.
If the RLD is equal to or greater than 17 mm in its largest dimension, the generic product should be no larger than the RLD in any single dimension, and no larger than the volume of the RLD. The largest dimension of a tablet should not exceed 22 mm and that capsules should not exceed a standard “00” size.

The guidance says additional flexibility may be given for products that are 8 mm or smaller in their largest dimension, “but efforts should be made to develop tablets and capsules that are of a similar size and shape to the RLD. Under the standard capsule size convention, the allowances described above will generally allow an increase of one capsule size, when the RLD capsule is of size 3 or smaller. When the RLD capsule is of size 2 or larger, an increase of one capsule size should only be considered when adequate justification can be provided for the size increase. These recommendations would allow an increase of one capsule size when the capsule size is less than capsule size 00.”

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