FDA Issues Guidance on Generic Tablets and Capsules

June 18, 2015

The agency publishes guidance on the physical attributes of generic tablets and capsules.

 

FDA issued guidance on June 18, 2015 regarding the physical attributes of generic tablets and capsules. The guidance states that, although generic drugs must be pharmaceutically and therapeutically equivalent to the brand-name version, the agency is concerned that a difference in the size and shape of a tablet or capsule might affect patient compliance or lead to medication errors. FDA recommends that generic-drug makers consider the physical attributes of a drug when they develop quality target product profiles (QTPPs) for generic products.

The guidance applies to abbreviated new drug applications (ANDAs) and their supplements for additional strengths submitted to the Office of Generic Drugs but does not apply to approved ANDAs already on the market. The guidance is specific to tablets and capsules and does not apply to other oral dosage forms.

Source: FDA.gov