FDA Releases Draft Guidance for Industry On Size, Shape of Generic Tablets, Capsules

The Food and Drug Administration Dec. 9 released a draft guidance for industry on the size, shape and other physical attributes of generic tablets and capsules intended to be swallowed intact.

A notice announcing the draft guidance was published in the Dec. 10 Federal Register (78 Fed. Reg. 74,154).

The agency said it is concerned that these characteristics of generic drugs are too varied compared to the originator drug and could affect patient outcomes. For example, studies show that tablet or capsule size can affect ease of swallowing, and generic tablets and capsules that are significantly larger ...