Generics Should Mimic Brand Counterparts, FDA says
The FDA wants generics makers to design tablets and capsules to be similar in size and shape to their reference listed drug to ensure patient acceptance and compliance, according to final guidance issued June 18.
To avoid such issues, the agency has set parameters for how much a generic may vary from its brand counterpart. For tablets smaller than 17 mm, the generic should be no more than 20 percent larger in any single dimension or more than 40 percent larger in overall volume, the FDA says. For tablets equal to or larger than 17 mm, the generic should be no larger in volume or any single dimension.
The largest dimension of a generic tablet should not exceed 22 mm, while capsules should not exceed the standard size 00, the FDA says. The agency may allow flexibility 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.
Other factors generics makers should consider are the weight of the tablet or capsule, as heavier products may have faster transit times than similarly sized lighter products, and the use and composition of coatings, which may affect the ease of swallowing.
The guidance is nearly identical to a draft version released in December 2013 (Generic Line, Jan. 1, 2014). Read Size, Shape and Physical Attributes of Generic Tablets and Capsules at www.fdanews.com/6-15-FDA-Guidance.pdf. — Jonathon Shacat
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